Merit’s Family of Drainage Products Supports Drainage Procedural Needs Every Step of the Way

banner-OneStep

By Alicia Armeli

Proper drainage is necessary for the removal of fluid buildup, as well as diagnosis. From access to intervention, Merit Medical provides a diverse portfolio of drainage products to support procedural needs throughout each step. With products designed in multiple configurations for specific drainage needs and kits that can be tailored to meet clinical challenges head-on, Merit helps deliver patient-care that’s efficient, while still being cost-effective.

Merit’s MAK-NV™ Introducer System

At the start of every drainage procedure, avoiding delays and complications could be as simple as choosing the right introducer system. Merit’s MAK-NV™ Introducer System and Valve Adapter—for mini access in non-vascular applications—were designed to help circumvent clinical challenges, such as introducer tip peel-back, inability to determine the exact location of the introducer tip, and difficulty visualizing the needle tip. In doing so, the MAK-NV Introducer System makes for easy visualization that leads to quick access into the drainage area.

VALVE ADAPTER FOR MAK-NV™

Starting with a tapered dilator and introducer tip, the MAK-NV allows for smooth transitions and movement over the guide wire, which can help minimize buckling and the incidence of introducer peel back during insertion. Introducer systems without tapered tips may be more prone to catching on tissue, potentially leading to peel back. Once inserted, the MAK-NV Introducer System’s distally placed radiopaque marker tip can help to determine its precise location more easily. For better needle visualization, the MAK-NV Needle has 1 cm echo-enhancement also placed at the distal end. Other needles without echo-enhancement technology may not be as easy to visualize when using ultrasound imaging.

One-Step™ Centesis Catheters

Echo-enhancement can be beneficial, particularly during interventional centesis procedures. Pneumothorax is a common complication of thoracentesis. Yet, studies have shown that using real-time ultrasonography is a modifiable factor that reduces pneumothorax risk.1 Merit’s One-Step™ Centesis Catheters have echo-enhanced needles that aid with visualization when using ultrasound. What’s more, the Valved One-Step™ Centesis Catheter has a self-sealing valve to decrease the risk of pneumothorax, as well as prevent fluid leakage during centesis procedures. Both the One-Step and Valved One-Step Centesis Catheters employ a tapered tip for smooth transitions that can decrease resistance and patient discomfort. To maximize performance, each device is designed with large drainage holes and pigtail tips.

Valved One-Step™ Centesis Catheter

Merit drainage products reach beyond centesis procedures. For biliary and all-purpose drainage needs, the ReSolve® line of biliary, locking, and non-locking drainage catheters are designed to help lessen trauma to surrounding tissue, support more precise placement, and provide unimpeded drainage.

Biliary drainage procedures are associated with significant catheter-related complications that occur in up to 22% of procedures.2 A common complication of percutaneous biliary drainage is catheter obstruction—usually the result of bile stones, biliary sludge, blood clots, or intestinal debris.2  Bench top data show Merit drainage catheters to have larger drainage holes, faster flow rates, larger drainage area, and larger catheter inner diameters when compared to leading competitors.

ReSolve® Biliary Locking Drainage Catheters

These qualities can be observed in the ReSolve® Biliary Locking Drainage Catheters, which have multiple large holes laid out in two different drainage hole patterns to accommodate targeted drainage of various lesion locations, thus offering up to 4x more drainage area when compared to leading competitors. In combination with radiopaque marker bands, the ReSolve Biliary Locking Drainage Catheter also has depth markers to facilitate fast and accurate positioning. To increase patient comfort and avoid irritating surrounding tissue, the hydrophilic-coated tip of the catheter is located inside an atraumatic pigtail curve. The ReSolve Biliary Locking Drainage Catheter can either be locked to prevent movement, or unlocked to reposition the catheter. If needed, its polyurethane material allows for long-term indwelling time.

ReSolve® Locking Drainage Catheter

For all-purpose drainage needs such as nephrostomy procedures, Merit offers the ReSolve® Locking and Non-Locking line of drainage catheters. Featuring many of the same advantages as their biliary counterpart, ReSolve Locking and Non-Locking Catheters employ hydrophilic coating and tapered tips. The tip of the locking drainage catheter can be found inside a locking pigtail, while non-radiopaque depth markers on the catheter shaft act as a reference for correct positioning. Large drainage holes of locking catheters maximize percutaneous drainage.

To emphasize cost savings and time efficiency, Merit offers ReSolve+™ Biliary Locking Drainage Catheters and ReSolve+™ Locking Drainage Catheters. Both offer all the same clinical benefits of their parent ReSolve products but with fixation device options. Each come with either the Revolution™ Catheter Securement Device or the StayFIX® Fixation Device.

Revolution™ Catheter Securement Device

Fixation and securing devices can improve patient comfort by reducing irritation to tissue surrounding the catheter, as well as avoiding the potential for catheter dislodgment. The Revolution Catheter Securement Device is a needleless and economical product designed with patient and clinician safety in mind. Easily positioned, the Revolution Catheter Securement Device holds a catheter in place, leaving the insertion site visible for cleaning and monitoring.

Its sister product—the suture-free StayFIX Fixation Device—is made only for percutaneous non-vascular catheters. This cost-savings option is designed to stop catheter migration, movement, and accidental removal. Made of soft water-resistant material, StayFIX remains secure for up to 7 days, allowing for patients to shower without removing the device. Additionally, its hydrocolloid material can reduce skin irritation by absorbing any fluid leaking from the insertion site.

Working alongside Merit’s catheters are several more accessories that together aim to improve the overall patient experience and increase procedural efficiency.

VacLok® Vacuum Pressure Syringe

This includes innovative devices created for common difficulties clinicians face. For example, abscess drainage and thrombus aspiration are often associated with clinician hand fatigue. To avoid this challenge and associated procedural delays, Merit has developed the VacLok® Vacuum Pressure Syringe. The VacLok creates a sustained negative vacuum by pulling back on the plunger and locking the device in place. With a clear polycarbonate barrel available in several sizes, fluid can be continuously collected and its volume monitored.

Drainage Depot™ Drainage Bags

For procedures that don’t use syringes but collect fluid in drainage bags, Merit supplies Drainage Depot™ Drainage Bags along with adjustable length drainage tubing and a VELCRO® brand leg strap that can meet a variety of patient sizes. With easy-to read volume markings, a twist valve for tidy disposal, and an internal anti-reflux valve—Depot Drainage Bags assist in improving the drainage process.

Merit Marquis® Series Stopcock

Taking efficiency to another level, the Merit Marquis® Series Stopcock accessories provide an added element of control to catheter procedures. With a larger easy-to-hold handle, the Marquis is simple to use with an effortless grip and turn motion. Described as “a cut above the rest,” the Marquis Series Stopcock is available in different pressure ratings, luer options, and has a patented airless rotator that prevents air bubbles from forming.

ReSolve Locking Drainage Catheter Tray

To increase convenience of drainage procedures, Merit offers standalone drainage options, kit configurations, or procedural trays. The MAK-NV kit comes with a variety of needles and guide wires, along with a large diameter introducer. Examples of ready-to-use trays include the ReSolve Locking Drainage Catheter Tray, the Safety Paracentesis Procedure Tray, and the Thoracentesis & Paracentesis Set (TAPS). Each kit includes all the products needed to perform a corresponding drainage procedure—minimizing procedural delays, while still ensuring a safe working environment.

Each member of Merit’s drainage family works together to provide an integrative approach to drainage procedures. By understanding and supporting clinician needs, Merit can help you deliver patient-centered, efficient, and cost-effective care. Welcome to the family.

Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

REFERENCES

  1. Gordon, C., Feller-Kopman, D., Balk, E., & Smetana, G. (2010). Pneumothorax following thoracentesis: a systematic review and meta-analysis. Archives of Internal Medicine, 170(4): 332-339. doi: 10.1001/archinternmed.2009.548. https://www.ncbi.nlm.nih.gov/pubmed/20177035
  2. Huang, S., Engstrom, B., Lungren, M., & Kim, C. (2015). Management of dysfunctional catheters and tubes inserted by interventional radiology. Seminars in Interventional Radiology, 32(2): 67-77. doi: 10.1055/s-0035-1549371. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4447882/

Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.

A STAR™ Is Born: Spinal Tumor Ablation with Radiofrequency Significantly Reduces Pain Associated with Metastatic Spinal Tumors

STAR Spinal Tumor Ablation with Radiofrequency

By Alicia Armeli

Each year, 400,000 people in the US alone suffer from bone metastases.1 Frequently seen in the spine—and specifically in the vertebrae—spinal tumors make up 40% of all bone metastatic disease.2,3 Pain associated with this condition can be excruciating.

Merit Medical’s STAR™ Tumor Ablation System (Spinal Tumor Ablation with Radiofrequency)—a unique device designed for the palliative treatment of painful metastatic spinal tumors—has been found to significantly reduce patient reported pain, often decreasing the need for pain medications, and improving overall quality of life.3,4

Historically, treating patients with metastatic spinal tumors has been a challenge. Traditional pain management is a balancing act that involves pain control, local tumor control to avoid neurological damage, and mechanical stabilization to preserve function.2  Treatments include pain medicines, chemotherapy, radiation therapy, and/or surgery. However, surgery may be avoided due to coexisting health problems or diminished life expectancy.3

A minimally invasive alternative that has been found to successfully treat spinal metastatic lesions is targeted radiofrequency ablation with the STAR Tumor Ablation System. Recognized in version 2014 of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Adult Cancer Pain as an interventional strategy for treatment of local bone pain, radiofrequency ablation can provide rapid pain relief by localized tumor destruction—often in a single outpatient session.5

Anchala et al. conducted a multicenter retrospective study of the STAR Tumor Ablation System involving 92 patients with a total of 128 metastatic spinal lesions from five academic centers who underwent targeted radiofrequency ablation between March 2012 and March 2013.3 Results published in Pain Physician Journal reported all 96 procedures to be technically successful without complication or thermal injury. Average Visual Analogue Scale (VAS) Scores showed that reported pain reduced significantly from 7.51 out of 10 before the procedure to 1.73 post-procedure, which stayed consistent at 6 months (1.75).

What’s more, the authors noted that 54% of the patients participating at the largest center were able to decrease their pain medication dosage. At the same center almost two-thirds of the lesions treated with the STAR Tumor Ablation System were located in the posterior vertebral body—a location previously considered difficult to access. Post ablation images confirmed the size of ablation zones matched those measured with device feedback and showed no further growth or canal extension of treated tumor.

Also significant to note, the STAR Tumor Ablation System was able to treat these patients without having to interrupt their primary cancer treatment. “For late-stage cancer patients, extreme back pain due to spinal tumors degrades quality of life; and until now, limited minimally invasive procedural options for immediate pain relief have been available,” said Nam D. Tran, MD, PhD, a neuro-oncology surgeon at Moffitt Cancer Center, Assistant Professor of Oncology and Neurosurgery at the University of South Florida College of Medicine in Tampa, Fla., and co-author of the study. “This multi-center study validates t-RFA (targeted radiofrequency ablation) as a treatment option that provides rapid, lasting pain relief without the need to interrupt the patient’s primary cancer therapy.”6

The STAR Tumor Ablation System procedure begins with a small puncture at the desired access site and the SpineSTAR® device is inserted into the affected vertebra by way of a working cannula. Active steering capability of the ablation instrument allows for precise navigation through the pedicle and into the desired areas of the vertebra-containing tumor. Once in place, radiofrequency energy is emitted through a bipolar electrode resulting in thermal necrosis of the adjacent tissue while two thermocouples on the electrode simultaneously monitor the tissue temperature. This real time feedback gives physicians the control to create site-specific ablation zones. The radiofrequency energy administration is stopped once the proximal thermocouple measures 50°C . When clinically indicated, the SpineSTAR device allows for precise repositioning within the vertebral body to produce overlapping ablation zones.

An advantage radiofrequency ablation therapy has is that it’s effective on its own and can also be used in conjunction with other treatments. Whether this means patients can continue their prescribed cancer regimen uninterrupted—as noted in the aforementioned study—or as part of a synergistic approach to pain management, ablation has the advantage of flexibility. Coupling pain management therapies can benefit patients with pain that’s hard to manage using traditional forms of treatment, such as radiation therapy.

Although a conventional course of radiation therapy delivered over a series of days to weeks is considered standard care for persistent pain, it has its drawbacks. Statistics show that approximately 60% of patients obtain partial pain relief and only 32% of patients respond with complete palliation.7 Additionally, pain relief following radiation therapy isn’t immediate and can take several weeks.2 Moreover, radiation treatment does have dosage limits. Once dose thresholds of the adjacent normal tissue, such as the spinal cord in the case of spinal metastatic lesions, have been met, recurrent pain at a previously treated site often can’t be retreated.2

A previous feasibility study suggested that combining radiation and ablation therapies may work together to achieve better outcomes compared to using each as a standalone treatment.8  The effect of combined treatments on metastatic spinal tumors was recently reported by Greenwood et al. who carried out a retrospective study, which analyzed medical records of 21 patients with 36 metastatic spine lesions—including radioresistant tumors—treated with the combination of radiation therapy and targeted radiofrequency ablation using the STAR Tumor Ablation System between March 2012 and June 2014.2

Post-procedure outcomes showed patient reported pain measured with the numerical rating scale (NRS) to decrease significantly from an average 8 out of 10 pre-treatment to 4.3 at 1-week and 2.9 at 4-weeks post-treatment. Opioid pain medication use also reduced in 62% of the patients and general activity level increased in 81% of patients at a 4-week follow-up. Post-procedural imaging showed stable treated disease in 12 of 13 and 10 of 10 patients at 3- and 6-months, respectively.

Based on these findings, the authors considered it effective to use ablation and radiation therapies together to treat pain in patients with metastatic spinal lesions and could be an option for those with radiation resistant tumors.

From its start in 1992 treating a handful of patients with benign bone tumors, radiofrequency ablation therapy transformed into an established method of treating metastatic bone disease.3

Almost two decades later in 2012, following FDA 510(k) clearance, DFINE Inc. introduced a percutaneous radiofrequency ablation device purpose built for the palliative treatment of spinal metastatic lesions. Acquired by Merit Medical earlier this year, DFINE Inc. and its unique line of medical devices—including the STAR Tumor Ablation System—are now a part of Merit’s growing portfolio of state-of-the-art oncology products.

It’s estimated that half or more of cancer patients may experience bone pain.1 Metastatic bone lesions are exceedingly common among these individuals and have been found to be the most prevalent cause of chronic pain in this population.3 These tumors have been seen in up to 80% of cancer patients at the time of death, with spinal metastases occurring in about 50% of these cases.3

The STAR Tumor Ablation System can be an option for these patients by offering rapid relief and improved quality of life.4 “If you look at a lot of the treatments that are used [to treat metastatic spine tumor pain], quality of life and life expectancy are not included. And they should be factored in,” explained Jack Jennings, PhD, MD, Diagnostic Radiologist, Associate Professor of Radiology at the Washington University School of Medicine, and Director of Musculoskeletal and Spine Interventions at Mallinckrodt Institute of Radiology in St. Louis, Mo. “Daily we physicians see these patients suffering with pain that has dramatically affected the life they have left.”9

 

REFERENCES

  1. Smith, H. (2011). Painful osseous metastases. Pain Physician, 14(4): E373-405. http://www.painphysicianjournal.com/linkout?issn=1533-3159&vol=14&page=E373
  2. Greenwood, T., Wallace, A., Friedman, M., Hillen, T., Robinson, C., & Jennings, J. (2015). Combined ablation and radiation therapy of spinal metastases: a novel multimodality treatment approach. Pain Physician, 18(6): 573-581. http://www.painphysicianjournal.com/current/pdf?article=MjQ1Mg%3D%3D&journal=92
  3. Anchala, P., Irving, W., Hillen, T., Friedman, M., Georgy, B., Coldwell, D., Tran, N., Vrionis, F., Brook, A., & Jennings, J. (2014). Treatment of metastatic spinal lesions with a navigational bipolar radiofrequency ablation device: a multicenter retrospective study. Pain Physician, 17(4): 317-327. http://www.painphysicianjournal.com/current/pdf?article=MjEyOA%3D%3D&journal=83
  4. Bagla, S., Sayed, D., Smirniotopoulos, J., Brower, J., Neal Rutledge, J., Dick, B., Carlisle, J., Lekht, I., & Georgy, B. (2016). Multicenter prospective clinical series evaluating radiofrequency ablation in the treatment of painful spine metastases. CardioVascular and Interventional Radiology, 39(9): 1289-1297. doi: 10.1007/s00270-016-1400-8. https://www.ncbi.nlm.nih.gov/pubmed/27343124
  5. National Comprehensive Cancer Network. (2016). NCCN Guidelines. Retrieved October 18, 2016 from https://www.nccn.org/professionals/physician_gls/f_guidelines.asp
  6. Merit Medical Systems Inc. (2014). Press Release: Multi-Center Trial Shows Significant Pain Relief For Spine Cancer Patients Following Targeted Radiofrequency Ablation Treatment. Retrieved October 20, 2016 from, https://www.merit.com/category/press-release/
  7. Sze, W., Shelley, M., Held, I., & Mason, M. (2004). Pallation of metastatic bone pain: single fraction versus multifraction radiotherapy – a systematic review of the randomised trials. The Cochrane Database of Systematic Reviews. (2): CD004721. https://www.ncbi.nlm.nih.gov/pubmed/15106258
  8. Di Staso, M., Zugaro, L., Gravina, G. L., Bonfili, P., Marampon, F., Di Nicola, L., Conchiglia, A., Ventura, L., Franzese, P., Gallucci, M., Masciocchi, C., Tombolini. V. (2011). A feasibility study of percutaneous radiofrequency ablation followed by radiotherapy in the management of painful osteolytic bone metastases. European Radiology, 21(9): 2004-2010. doi: 10.1007/s00330-011-2133-3. https://www.ncbi.nlm.nih.gov/pubmed/21533865
  9. Merit Medical Systems Inc. (2016). STAR™ Tumor Ablation System. Retrieved October 17, 2016, from https://www.merit.com/interventional-oncology-spine/spine-ablation/ablation/star-tumor-ablation-system/

Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.

Achieve Radial Access with Ease

Merit Medical PreludeEase Hydrophilic Sheath Introducers

By Alicia Armeli

PreludeEase™—Merit Medical’s newest line of Hydrophilic Sheath Introducers—has made the transradial artery approach even better. Studies show that hydrophilic coating on sheath introducers can reduce the incidence of artery spasm and improve patient comfort during transradial diagnostic and interventional coronary procedures.1

In recent years, the transradial approach has become increasingly popular for diagnostic and interventional coronary procedures. In comparison to transfemoral access, the transradial approach is linked to fewer vascular complications, shorter hospital stays, and reduced mortality.2 Financially, using the transradial technique may reduce direct and indirect hospital costs, while minimizing the overall financial burden from a larger social perspective.3,4

Notwithstanding these benefits, vascular complications can arise. More specifically, radial artery spasm is a common complication during transradial procedures and can lead to severe patient discomfort and diminished procedural success.1,5

A team of researchers at the Liverpool Heart and Chest Hospital in Liverpool, UK, examined the impact hydrophilic-coated sheath introducers had on the rate of radial artery spasm.1 In all, 790 patients scheduled for a transradial coronary procedure were randomly assigned hydrophilic-coated or uncoated sheath introducers. Results published in the Journal of the American College of Cardiology showed that radial artery spasm was seen significantly less in patients using a hydrophilic-coated sheath introducer (19.0% vs. 39.9%). Within the hydrophilic-coated group, less discomfort was also reported (15.1% vs. 28.5%). Sheath length didn’t influence these outcomes.

These results only mirror findings of numerous other studies. Saito et al. found sheath introducers with hydrophilic coating to lessen friction resistance by 70% in an in vitro model, which helped with sheath removal.6

A study published in Catheterization and Cardiovascular Interventions further investigated whether hydrophilic coating reduced the required force of sheath removal and any associated patient discomfort.5 Through a randomized double-blind comparison, Kiemeneij et al. analyzed 90 patients undergoing transradial percutaneous coronary intervention. Each patient received a sheath of identical length and diameter—the only difference being the presence or absence of hydrophilic coating.

Findings showed 3 patients (7%) in the coated group reported discomfort versus 12 patients (27%) in the uncoated group. Required force, measured in maximum and mean pullback force, was also significantly lower in the coated group.5

In addition to hydrophilic coating that extends to the sheath tip, the kink-resistant PreludeEASE tubing helps to provide procedural reliability. Smooth transitions between wire to dilator and dilator to sheath were designed for ease of insertion and can help enhance patient comfort. Available in 4F through 7F diameters and multiple lengths, PreludeEASE anticipates various clinical needs and diverse patient anatomy without compromising its slim profile and large inner diameter.

PreludeEASE sheaths are available in a variety of kit configurations, including one and two-part access needles, several guide wire options, a BowTie™ Guide Wire Insertion Device, and more. In addition, Merit can customize PreludeEASE radial access kits to meet both specific and a wide variety of clinical needs.

PreludeEASE Hydrophilic Sheath Introducers complement Merit’s growing line of products designed to support radial access procedures from preparation to hemostasis. In this way, PreludeEASE can help interventional cardiologists not only perform radial access procedures with success—but with ease.

Please consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.

REFERENCES

  1. Rathore, S., Stables, R., Pauriah, M., Hakeem, A., Mills, J., & Palmer, N. et al. (2010). Impact of length and hydrophilic coating of the introducer sheath on radial artery spasm during transradial coronary intervention. JACC: Cardiovascular Interventions, 3(5): 475-483. https://www.ncbi.nlm.nih.gov/pubmed/20488402
  2. Schussler, J., Vasudevan, A., von Bose, L., Won, J., & McCullough, P. (2016). Comparative efficacy of transradial Versus transfemoral approach for coronary angiography and percutaneous coronary intervention. The American Journal Of Cardiology, 118(4): 482-488. http://dx.doi.org/10.1016/j.amjcard.2016.05.038
  3. Amin, A., House, J., Safley, D., Chhatriwalla, A., Giersiefen, H., & Bremer, A., et al. (2013). Costs of transradial percutaneous coronary intervention. JACC: Cardiovascular Interventions, 6(8): 827-834. doi: 10.1016/j.jcin.2013.04.014. https://www.ncbi.nlm.nih.gov/pubmed/23871512
  4. Kołtowski, Ł., Filipiak, K., Kochman, J., Pietrasik, A., Huczek, Z., & Balsam, P. et al. (2016). Cost-effectiveness of radial vs. femoral approach in primary percutaneous coronary intervention in STEMI – Randomized, control trial. Hellenic Journal Of Cardiology, 57(3): 198-202. http://dx.doi.org/10.1016/j.hjc.2016.06.005
  5. Kiemeneij, F., Fraser, D., Slagboom, T., Laarman, G., & van der Wieken, R. (2003). Hydrophilic coating aids radial sheath withdrawal and reduces patient discomfort following transradial coronary intervention: A randomized double-blind comparison of coated and uncoated sheaths. Catheterization And Cardiovascular Interventions, 59(2): 161-164. http://dx.doi.org/10.1002/ccd.10444
  6. Saito, S., Tanaka, S., Hiroe, Y., Miyashita, Y., Takahashi, S., & Satake, S. et al. (2002). Usefulness of hydrophilic coating on artery sheath introducer in transradial coronary intervention. Catheterization And Cardiovascular Interventions, 56(3): 328-332. http://dx.doi.org/10.1002/ccd.10202

Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.

Merit Med 4Q and Year End 2016 conference call

http://edge.media-server.com/m/p/h5izv63d

February 21st 2017 / 3pm MT

HeRO Graft - Hemodialysis Reliable Outflow

What Is the Super HeRO?

superhero

By Alicia Armeli

Short of leaping tall buildings at a single bound, the Super HeRO™ Adapter is living up to its name.

“The Super HeRO gives you options to customize your approach—unique patients unique procedures.” –Dr. Stephen E. Hohmann, MD, FACS, Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas, Texas

“The new HeRO Graft Adaptor gives vascular access surgeons a variety of options on which graft to use instead of the standard PTFE. I currently use the ACUSEAL graft, which can be cannulated in 24 hours and there is no need for a bridge catheter. Removing the permcath at the same time as the insertion of the HeRO Graft decreases the risk of infection for these dialysis patients with central vein pathology and no need to come back for an additional procedure to remove the catheter.” –Dr. Jesse Garcia, MD, MedStar Washington Hospital Center, Washington, DC

“The Hero Adapter has opened a new window of opportunity in the creation and rescue of complex hemodialysis access.”—Dr. David Varnagy, MD, FACS, Vascular Institute of Central Florida, Orlando, Fla.

These are only a few of the positive comments made by vascular surgeons regarding the newest addition to the growing family of Merit Medical dialysis devices. The Super HeRO Adapter and its accompanying HeRO Ally™ Revision Kit are a one-of-a-kind dynamic duo of dialysis technology that offer surgeons the same safety and efficiency of the original HeRO™ (Hemodialysis Reliable Outflow) Graft—but with the added flexibility of more graft options to choose from.

Proper vascular access is essential for dialysis adequacy. And yet vascular access complications are the leading cause of morbidity among dialysis patients and add to high healthcare costs.1 It’s these same complications that lead to hospitalization of dialysis patients between one and two times every year.2

Central venous stenosis is a common and serious vascular complication that involves the narrowing of the veins leading to the heart. These central veins are often the final common route used for dialysis, and once occluded, vascular access is eventually lost and life expectancy diminishes.3

This is a serious health risk for patients requiring dialysis, especially those who are catheter-dependent. Central venous stenosis is linked to external catheterization, as studies have shown that approximately one out of four patients with venous stenosis has a history of central venous catheter placement.4

Catheters are used in approximately 80% of patients starting dialysis and 25% of all prevalent patients as a bridge to permanent vascular access or because all options for permanent access have been exhausted.5  Patients using a catheter are not only at risk for venous stenosis but are four times more susceptible to access-related infection than patients with a graft and eight times more at risk than those who have a fistula.6

To bypass venous stenosis and improve long-term dialysis, various permanent subcutaneous arteriovenous graft devices have been manufactured as a solution for dialysis patients who have exhausted all other access options.

One such product called the HeRO Graft was approved by the FDA in 2008. In comparison to catheters, it’s the only clinically proven permanent subcutaneous arteriovenous graft to reduce the risk of vascular access-related infections by 69%, improve adequacy of dialysis by up to 32% (1.7 Kt/V), and cut interventions needed to maintain access function by more than half.7 Studies have also linked the HeRO Graft to high cumulative patency rates that reach 87% at two years.8

But unlike other graft products, the HeRO Graft doesn’t depend on venous anastomosis to bypass venous stenosis. Instead, a radiopaque silicone Venous Outflow component reinforced with kink and crush-resistant nitinol braid is placed in the right atrium and securely attaches to an adjacent ePTFE hemodialysis graft by way of a proprietary titanium connector. This mechanism allows for blood to return from the veins back to the heart.

Now, eight years after the launch of the HeRO Graft, the Super HeRO Adapter emerges as an additional way to help access-challenged patients with central venous stenosis.

superheroadapterseal_sm

Graft compatibility is what makes the Super HeRO Adapter a one-of-a-kind product and a superior alternative to catheters. By having the same safety, dialysis adequacy, and patency advantages of the standard HeRO Graft but with a wider range of compatible graft products to choose from, using the Super HeRO could mean the difference between contracting and avoiding infection.

Researchers at the University of Miami Hospital in Miami, Fla., demonstrated the validity of this premise by examining the safety and efficacy of the standard HeRO Graft in comparison to tunneled dialysis catheters. Thirty-six access-challenged patients with venous stenosis were implanted with the HeRO Graft and followed over a course of almost 9 months.7

Results published in the Journal of Vascular Surgery showed that access-related bacteremia rates were significantly lower among patients using the HeRO Graft (0.7 events per 1000 days), but that infection only occurred during the bridging period when a catheter was implanted prior to the HeRO graft being used.7

Circumventing the 2-4 week bridging period and avoiding the risk of infection is one of the major advantages of the Super HeRO Adapter, especially since infection is a frequent cause of hospitalization and the second most common cause of death among dialysis patients.9 By connecting the Venous Outflow component to an early cannulation graft, a patient can be implanted today and dialyzed the next, virtually eliminating the risk of access-related infection due to a bridging catheter.

Early cannulation grafts compatible with the Super HeRO Adapter include GORE® ACUSEAL grafts and FLIXENE® Standard Wall grafts. If an early cannulation graft isn’t used, the Super HeRO Adapter also works with single-wall options, including GORE-TEX® and IMPRA®.

Cost savings advantages seen with the standard HeRO Graft can also be applied to the Super HeRO Adapter. A US healthcare model for provision of dialysis access predicted that in comparison to catheters, using the HeRO Graft could result in an average of 23% annual savings.10 Dialysis centers could save over $3000 per patient each year.11 And hospitals can save thousands in hefty admission costs that accrue because of device-related infections—rates that would commonly range between $23K to $56K per stay.12,13

These cost savings are being recognized around the globe. At the University Hospital at Birmingham, a British economic study analyzed the cost of introducing the HeRO Graft in the UK.14 Shakarchi et al. compared the cost of the HeRO Graft versus tunneled dialysis catheters by carrying out a 1-year cost-consequence decision analytic model that measured vascular access function, infection, device thrombosis, and associated costs over four 3-month intervals.

Based on a 100-patient cohort managed with the HeRO Graft, results of the study revealed 6 fewer failed devices, 53 fewer access-related infections, and 67 fewer device thromboses compared to patients managed with catheters.14  The authors concluded that even though the initial device and placement costs for the HeRO Graft are more expensive than catheters, the savings that occur because of fewer device complications and longer effective device patency minimizes these costs. Overall, a net 1-year savings of £1200 per patient was estimated for patients managed with the HeRO Graft.

Another cost-effective option offered by the Merit team is the HeRO Ally Revision Kit—a viable solution for long-term dialysis patients who still have a functioning Venous Outflow component—but need a new graft. The Revision Kit contains the tools needed to place a new Super HeRO compatible graft, which includes the Adapter, Support Seal, Graft Expander, Vascular Clamp, and Syringe for Heparinized Saline. Sold separately from the Super HeRO itself and compatible grafts, the HeRO Ally gives clinicians the freedom to purchase their compatible graft of choice.

By using these tools—whether it’s the Super HeRO, HeRO Ally Revision Kit, or the standard HeRO Graft—clinicians are offering access-challenged patients who’ve exhausted all other options a longer life expectancy and—above all—hope.

“It’s exciting to know that there’s something out there,” said Kay, referring to the HeRO Graft.15 After experiencing failure with traditional access grafts and catheters, Kay was faced with no other options—until her doctor suggested the HeRO Graft. “I’m not so depressed now,” Kay told Merit Medical. “I’m on the go more. I go places more and do things more.”

The HeRO products can also give loved ones peace of mind. “We have less to worry about,” explained Katie, Kay’s daughter and caregiver.14 “We’re not worried about infection. We’re not worried about clotting. The dialysis is just more efficient. She feels better.”

Merit Medical’s HeRO technology not only saves the lives of countless dialysis patients, but also enhances them. “I consider it my lifeline,” Kay said. “It keeps me alive.” And if that’s not the true mark of a superhero, I don’t know what is.

 

REFERENCES

  1. Hemachandar, D. (2015). Analysis of vascular access in haemodialysis patients—single center experience. Journal of Clinical and Diagnostic Research, 9(10): OC01-4. doi: 10.7860/JCDR/2015/13342.6611. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4625272/
  2. Adib-hajbagheri, M., Molavizadeh, N., Alavi, N. S., & Abadi, M. H. M. (2014). Factors associated with complications of vascular access site in hemodialysis patients in Isfahan Aliasghar hospital. Iranian Journal of Nursing and Midwifery Research, 19(2): 208-214. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4020033/
  3. Beathard, G. A. (2016). Central vein stenosis associated with hemodialysis access. Retrieved October 5, 2016, from http://www.uptodate.com/contents/central-vein-stenosis-associated-with-hemodialysis-access
  4. Kundu, S. (2009). Central venous obstruction management. Seminars in Interventional Radiology, 26(2): 115-121. doi: 10.1055/s-0029-1222454. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3036427/
  5. Al-Solaiman, Y., Estrada, E., & Allon, M. (2011). The spectrum of infection sin catheter-dependent hemdialysis patients. Clinical Journal of the American Society of Nephrology, 6(9): 2247-2252. doi:  10.2215/CJN.03900411. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3359000/
  6. National Kidney Foundation. (2012). A Clinical Update on an Alternative Vascular Access for the Catheter-Dependent Hemodialysis Patient. Retrieved October 6, 2016, from https://www.kidney.org/sites/default/files/12-10-4487_KBB_ClinicalUpdateOnAlternateiveVA.pdf
  7. Katzman, H., McLafferty, R., Ross, J., Glickman, M., Peden, E., & Lawson, J. (2009). Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. Journal Of Vascular Surgery, 50(3): 600-607.e1. doi: 10.1016/j.jvs.2009.04.014. http://dx.doi.org/10.1016/j.jvs.2009.04.014
  8. Gage, S., Katzman, H., Ross, J., Hohmann, S., Sharpe, C., Butterly, D., & Lawson, J. (2012). Multi-center experience of 164 consecutive Hemodialysis Reliable Outflow [HeRO] Graft implants for hemodialysis treatment. European Journal Of Vascular And Endovascular Surgery, 44(1): 93-99. doi: 10.1016/j.ejvs.2012.04.011. http://dx.doi.org/10.1016/j.ejvs.2012.04.011
  9. Laurin, L., Harrak, H., Elftouh, N., Ouimet, D., Vallee, M., Lafrance, J. (2015). Outcomes of infection-related hospitalization according to dialysis modality. Clinical Journal of the American Society of Nephrology, 10(5): 817-824. doi: 10.2215/ CJN.09210914. http://cjasn.asnjournals.org/content/10/5/817.full
  10. Dageforde, L., Bream, P., & Moore, D. (2012). Hemodialysis Reliable Outflow (HeRO) device in end-stage dialysis access: a decision analysis model. Journal Of Surgical Research, 177(1): 165-171. doi: 10.1016/j.jss.2012.04.041. http://dx.doi.org/10.1016/j.jss.2012.04.041
  11. Yost, L., Dinwiddie, L. (2010, Nov.). Impact of the use of the HeRO vascular access graft vs. tunneled dialysis catheters on dialysis provider economics in an era of bundling. Poster session presented at ASN, American Society of Nephrology, Denver, CO.
  12. Ramanathan, V., Chiu, E., Thomas, J., Khan, A., Dolson, G., & Darouiche, R. (2007). Healthcare costs associated with hemodialysis catheter–related infections: a single‐center experience. Infection Control And Hospital Epidemiology, 28(5): 606-609. doi: http://dx.doi.org/10.1086/513617
  13. O’Grady, N., Dellinger, E., Gerberding, J., Heartd, S. Maki, D., Masur, H., McCormick, R., Mermel, L., Pearson, M., Raad, I., Randolph, A., & Weinstein, R. (2002). Guidelines for the prevention of intravascular catheter-related infections. The Hospital Infection Control Practices Advisory Committee, Center for Disease Control and Prevention, U.S. Pediatrics, 110(5): e51.
  14. Al Shakarchi, J., Inston, N., Jones, R., Maclaine, G., & Hollinworth, D. (2016). Cost analysis of the Hemodialysis Reliable Outflow (HeRO) Graft compared to the tunneled dialysis catheter. Journal Of Vascular Surgery, 63(4): 1026-1033. doi: 10.1016/j.jvs.2015.10.089. http://dx.doi.org/10.1016/j.jvs.2015.10.089
  15. Merit Medical Systems, Inc. (2016, Aug 26). HeRO® Graft – Kay and Katie: A Patient’s Story of Receiving a HeRO Graft. [Video File]. Retrieved from https://youtu.be/OztHLxZ2CG8

Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.

Physician Faculty to Impart their Commitment to Interventional Spine Procedures during Upcoming Education Program

Amish Doshi, MD Course Director

Amish Doshi, MD
Course Director

As an interventional neuroradiologist, Dr. Amish Doshi, Associate Professor of Radiology and Neurosurgery, Chief of Neuroradiology and the Director of Spine Imaging and Interventions at the Mount Sinai Hospital in New York City, has had the opportunity to treat a variety of disorders of the head, neck and spine.  Throughout his career, he has developed a special interest in the diagnosis and treatment of spine disorders through both imaging interpretation and spinal interventional procedures.

After years of observing benefits for his patients, he chooses to focus on vertebral augmentation and radiofrequency ablation to treat spinal fractures and spinal tumors. With improvements in cement viscosity, navigational instrumentation and use of radiofrequency technology, especially in the field of spinal tumor treatment, Dr. Doshi has increased his focus on the treatment of local tumor control and pain palliation in the setting of metastatic disease to the spine.

Dr. Doshi will imbue his knowledge of and experience in targeted vertebral procedures later this week at the Interventional spine training course hosted by Merit Medical at Mount Sinai. During the course, physicians will gain hands-on cadaver experience with the minimally invasive procedures of vertebral augmentation, vertebroplasty and spine tumor ablation, using Merit’s StabiliT® Vertebral Augmentation Systems and the STAR™ Tumor Ablation System.

Other program faculty members include Dr. Reade De Leacy, Director of Neurointerventional Spine for Mount Sinai Hospital: Dr. Ramsey. Abadir, Chairman of Radiology and Director of Interventional Radiology, Orange Regional Medical Center in Middletown, NY; Dr. Michael Hallisey, Chief, Vascular & Interventional Radiology, Hartford Hospital, Hartford, CT; Dr. Avi Beck, Quantum Imaging and Therapeutic Associates, Lewisberry, PA; and Jennifer Merhar, R.N., Jefferson Radiology, Outpatient IR Center, Hartford, CT.

Merit Medical plans to announce its 2017 schedule for Interventional spine training courses in the coming weeks. To learn more, visit Merit.com/PEC.

Merit Medical Launches Think Hero Graft Training Program

Merit Medical’s inaugural Think HeRO Graft Training Course was held at the Methodist Institute for Technology, Innovation & Education (MITIE) in Houston, TX on September 22 and 23.

ThinkHeroGraft is an education program that prepares surgeons and physicians to use the HeRO® Graft as a method for end-stage dialysis access, for patients with central venous stenosis who would otherwise be catheter-dependent.

Proctor Dr. Eric Peden, Chief of Vascular Surgery at the Houston Methodist DeBakey Heart & Vascular Center, led engaging discussions and hands-on training with a cadaver lab, which allowed attendees to practice actual implantation procedure steps.

Dr. Peden, who has over 10 years of experience working with HeRO Graft and was one of its principal investigators, shared his best practices in patient selection, implantation techniques and maintenance strategies.

Attendees learned the clinical science and healthcare economics of the Hero Graft, identification of patient candidates and contraindications, as well challenges and complications.

Please contact your Merit Representative for future Think Hero Graft training opportunities.

HeRO1

HeRO2

Merit Medical Hosts Physician Education Course at Washington University in St. Louis

September 17th, 2017

Merit Medical hosted 12 physicians for a Physician Education Course on minimally invasive vertebral therapies on Saturday, September 17th, 2017 at Washington University in St. Louis.  The Physician Education Course program is a focused cadaver lab workshop designed to deliver detailed information on appropriate use of Merit’s technology and the minimally invasive procedures of vertebral augmentation, vertebroplasty and spine tumor ablation, using Merit’s StabiliT® Vertebral Augmentation Systems and the STAR™ Tumor Ablation System. Expert faculty is chosen to present the supporting clinical data and share their tips and tricks.

To learn more or sign up for a future course visit https://www.merit.com/pec/

The DriPAD™: Super Absorbent Technology that Helps to Provide Better Patient Care

DriPAD Super Absorbent Technology

From assisting a patient with incontinence care, to assisting in reducing room-turn over time, the DriPAD has numerous applications and can be used in multiple areas within a hospital. Having up to 10x more absorption power than alternative pads, using a product with a higher absorbency means fewer pads used per patient—which supports hospital cost-cutting initiatives and reduces biohazard waste disposal costs.

Through super absorbent technology, the DriPAD soaks up to 35x its weight in fluids. Each DriPAD features a robust polypropylene backing to provide a barrier that prevents leakage with a specially treated absorbent core that wicks moisture away from the skin for ultimate protection. This can help provide better patient care both during procedures and in the post-surgical-care environment.

The DriPAD not only keeps patients dry, but it also helps control odors through an EPA registered Silver Ion agent. Many hospitals are looking for ways to continuously deliver positive outcomes while being environmentally friendly. Furthermore, just one DriPAD replaces many underpads, reducing the amount of unnecessary trash in landfills.

Available in various sizes and absorption capacities, the DriPAD extends its care beyond the hospital, making it easy to use at home.

Merit Medical Acquires DFINE, Inc.

SOUTH JORDAN, Utah, July 06, 2016 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has acquired DFINE, Inc. headquartered in San Jose, California, in a merger transaction through which DFINE has become a wholly-owned subsidiary of Merit.

The purchase consideration was approximately $97.5 million in cash and was financed by a group of banks led by Wells Fargo and included Bank of America, HSBC and U.S. Bank.

DFINE produced revenues of $33.4 million in 2015, with approximately 75% of revenues generated in the United States and 25% outside the United States.  DFINE’s products are directed to vertebral augmentation (kyphoplasty and vertebralplasty), as well as targeted radiofrequency ablation of metastatic spinal tumors.  DFINE’s product lines have 510(k) clearance and CE marking.

“We are delighted to have DFINE join Merit,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.  “Our relationship began a few years ago when Merit was asked to provide key device components for DFINE’s StabiliT® and StabiliT MX® products.  In addition to the spinal compression fracture segment, we believe DFINE’s Star™ Tumor Ablation Kit complements and enhances Merit’s oncology business.”

“We plan to combine Merit’s oncology segments, including embolics, microcatheters and biopsy products into a newly created interventional oncology and spine division (IOS),” Lampropoulos said.  “We believe the restructuring of the sales divisions – cardiovascular, peripheral and IOS – will enable us to devote greater focus on Merit’s broad portfolio of products, align our sales and marketing efforts with Merit’s goal of achieving a more therapeutic and disease state centered product offering, and enhance opportunities for future growth.”

“We believe the opportunity for growth with these best-in-class products is substantial in the United States and also in international markets where Merit already has a broad footprint,” Lampropoulos continued.  “Although DFINE has a presence in Germany and Austria, as well as limited distribution partners, we believe there are many opportunities in Australia, Canada, Japan, China, the Nordic countries and other regions.  We anticipate that DFINE’s IP portfolio of approximately 110 U.S. and international patents will provide substantial coverage for many years ahead.”

The effect of the DFINE acquisition on Merit’s non-GAAP earnings for the balance of 2016 is expected to be neutral due to business restructuring and consolidation expenses and is expected to be dilutive on a GAAP basis by $0.24-$0.26 per share due to intangible amortization and one-time reorganization costs.  In 2017, Merit anticipates the effect of the acquisition on Merit’s non-GAAP earnings to be $0.05-$0.08 per share and to be dilutive on a GAAP basis by $0.05-$0.07 per share.  Merit believes the acquisition will increase its gross margin by approximately 80 basis points on a non-GAAP basis and 55 basis points on a GAAP basis.

Canaccord Genuity acted as Merit’s financial advisor for this transaction.  Piper Jaffray acted as DFINE’s financial advisor.

CONFERENCE CALL TODAY Merit invites all interested parties to participate in its conference call discussing the acquisition (conference ID 41983902) today, Wednesday, July 6, 2016, at 11:00 a.m. Eastern (10:00 a.m. Central, 9:00 a.m. Mountain, and 8:00 a.m. Pacific).  The domestic telephone number is (844) 578-9672, and the international number is (508) 637-5656.  A live webcast of the call and a slide deck showcasing the products and details of the DFINE acquisition are available at www.merit.com.

ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy.  Merit serves hospitals, acute care facilities and clinics worldwide, with a domestic and international sales force totaling approximately 200 individuals.  Merit employs approximately 4,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; and Mannheim, Germany.

Statements contained in this release which are not purely historical, including, without limitation, statements regarding anticipated revenues, earnings or other financial items; Merit’s plans and objectives for future operations; proposed products or services; integration, development or commercialization of the DFINE operations and assumptions underlying any of the foregoing , are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2015. Such risks and uncertainties include risks relating to Merit’s acquisition of DFINE; Merit’s efforts to integrate, manage and develop DFINE’s operations and products; expenses associated with the integration, management and development of those operations and products; product recalls and product liability claims; expenditures relating to research, development, testing and regulatory approval of Merit’s products (including the DFINE products) and risks that such products may not be developed successfully or approved for commercial use; regulation of the medical device industry; Merit’s need to generate sufficient cash flow to fund its debt obligations, capital expenditures, and ongoing operations; restrictions on Merit’s liquidity or Merit’s ability to operate its business in compliance with its debt agreements; possible infringement of its technology (including the DFINE technology) or the assertion that such technology infringes the rights of other parties; changes in the prices or supply of commodity components; changes in economic and industry conditions in the United States and other countries; termination or interruption of relationships with suppliers, or failure of suppliers to perform; fluctuations in exchange rates; development of new products and technology that could render Merit’ products (including the DFINE products) obsolete; changes in key personnel; potential healthcare regulatory and policy changes; and other factors referred to in Merit’s Annual Report on Form 10-K for the year ended December 31, 2015 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.

Contact: Anne-Marie Wright, Vice President, Corporate Communications Phone: (801) 208-4167  e-mail: [email protected]  Fax: (801) 253-1688

I Am Merit: Matt Wiker, Director of Global Materials

As Merit Medical’s global footprint continues to grow, Matt Wiker, Merit Medical Director of Global Materials, speaks about his role to ensure that Merit’s customers, and ultimately patients and hospitals, receive high quality products when and where they need them.

I Am Merit: Allen Guo

Allen Guo, Senior Operations Manager

My Opportunities in China with Merit:

I started working at Merit 6 years ago as an Operations Supervisor. Before that, I worked at GE Healthcare under the medical system machines division in Beijing. I was promoted to Operations Manager after 1.5 years and was further promoted to my current position of Senior Operations Manager after another 2 years. My operations coverage has also been extended from Mainland China to the rest of the Hong Kong, Taiwan, Southeast Asia areas and Korea. The reason why I stayed at Merit is really simple and straight-forwarded: great people and plenty of opportunities.

Merit in Mainland China:

In 2010, I was one of 3 people working for Merit in a small 700-square-meter warehouse (7534 square feet). Now, I have a team of 10 people with 8 employees working at our newly-established 1800-square-meter (20,000 square feet) warehouse and distribution center handling distribution in Mainland China. One team member looks after the forecast and planning in Mainland China and the final team member is located in Hong Kong and provides operation supports to the region. Over the past 5-6 years Merit has dramatically expanded with a steady double-digit growth rate. We have increased the numbers of sales licenses to over 50. These licenses are issued by the Chinese government to sell medical devices within China. One of the major growth factors can be attributed to Merit’s strong sales team, who work with 400 different distributors in China’s key cities.

Facing the Challenge of Growth:

As a department head leading the Asia operation, I have built up a reliable, responsible and passionate operation team. I lead my team to overview the sales forecasts to establish a proper supply chain, while maintaining a high order fulfillment rate for the entire Asia region. Apart from managing Merit’s warehouse in Beijing, we also have a third party logistics warehouse in Hong Kong as the regional distribution center.

Merit’s Vision in China:

Being customer oriented is the main vision that I focus on. Operation is a supporting function that I have two groups to serve, my internal and external customers.  Sales and Marketing teams are my internal customers. Mutual understanding on their specific needs and special requests are the vital elements for me to provide necessary supports to them. Distributors and hospitals, who purchase our products are my external customers. My main focus is to lean the operation process in order to improve the order implementation efficiency; as well as improve the forecast accuracy and the order fulfillment rate.

Friends, Family and Football:

When I’m not analyzing supply/demand numbers, I like to play football with my friends, not American football but European football, “soccer”. I also like to go to gym after work. The majority of my leisure time is spent with my family. I’ve been married for 8 years to my wife Yuanyuan and have two daughters. One is 5-years-old, her name is Sherry and her little sister has just arrived last month on March 29. I call her little beauty at the moment, but still haven’t given her an English name. We are welcome to any suggestion!

New High Flow Pigtail Valved One-Step™ Centesis Catheters

OSV_OS_PigStaightFullgreen

We are excited to announce the release of the new high flow Pigtail Valved One-Step™ Centesis Catheter!

These catheters have been designed for safe, controlled insertion with decreased procedure times.

The distal obturator prevents the needle from puncturing and shearing the catheter, and protects the clinician from accidental needlestick. The self-sealing valve also minimizes the risk of air infiltration, and fluid leakage.

The sharp needle and smooth transitions ease insertion and decrease patient discomfort, while the depth markers and echo-enhanced needle help with fast and accurate placement.

Procedure times may be decreased due to the fast flow rates. When compared with a leading competitor, the high flow Valved One-Step Centesis Catheter has a 16% faster flow rate*. The fast flow rates are due to the pigtail protecting the large drainage holes from occlusion, kink-resistant material, and large catheter and hub inner diameters.

To incorporate the high flow Pigtail Valved One-Step Centesis Catheter into your practice, contact your Merit Medical sales professional today or visit merit.com to learn more.

*Tested with 5F X 10 cm straight catheters

New High Flow Pigtail Valved One-Step™ Centesis Catheters

OSV_OS_PigStaightFullgreen

We are excited to announce the release of the new high flow Pigtail Valved One-Step™ Centesis Catheter!

These catheters have been designed for safe, controlled insertion with decreased procedure times.

The distal obturator prevents the needle from puncturing and shearing the catheter, and protects the clinician from accidental needlestick. The self-sealing valve also minimizes the risk of air infiltration, and fluid leakage.

The sharp needle and smooth transitions ease insertion and decrease patient discomfort, while the depth markers and echo-enhanced needle help with fast and accurate placement.

Procedure times may be decreased due to the fast flow rates. When compared with a leading competitor, the high flow Valved One-Step Centesis Catheter has a 16% faster flow rate*. The fast flow rates are due to the pigtail protecting the large drainage holes from occlusion, kink-resistant material, and large catheter and hub inner diameters.

To incorporate the high flow Pigtail Valved One-Step Centesis Catheter into your practice, contact your Merit Medical sales professional today or visit merit.com to learn more.

*Tested with 5F X 10 cm straight catheters

Merit Medical is Looking Forward to SIR this Weekend

Liu-and-Klass

Merit Medical and ThinkRadial will host several exciting events at the Society of Interventional Radiology annual meeting in Vancouver, BC, Canada from April 3-6. A series of activities taking place in Merit’s booth, #419, will provide attendees with a chance to learn about Merit’s innovative offerings through both hands-on experience and interactive presentations from transradial intervention and embolotherapy experts.

The first of Merit’s live presentations will take place from 9:30 am to 10:30 am on April 5. In this session, Dr. David Liu, MD, FRCPC, FSIR, will discuss “The Development and Evolution of a Hepatocellular Carcinoma Embolotherapy Program: Rationale, Experience and Approach at Vancouver General Hospital”. From 12:00 pm to 1:00 pm on April 5, Dr. Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, will host “Transradial Approach – Beyond the Basics: A Discussion of Cases and Tips With Expert Interventional RadialistTM, Dr. Darren Klass.”

Booth visitors will also have several opportunities to interact with and learn more about Merit’s product line supporting transradial intervention, including the most comprehensive offering of transradial access tools for Interventional Radiology; patient set-up, access, angiography, intervention and hemostasis, and for the first time, the Performa® Transradial Peripheral Angiographic catheter in longer lengths for peripheral radial access. ThinkRadial’s one-of-a-kind radial vascular model will also be available for hands-on product demonstrations.

Merit will also showcase products dedicated to the latest in embolotherapy interventions, including Embosphere® Microspheres, QuadraSphere® Microspheres (cleared in US and now additionally indicated for hepatoma), and HepaSphereTM Microspheres (indicated for use with or without doxorubicin outside the US).

At SIR, Merit will also showcase the following products:

  • HeRO® Graft, recently acquired from Cryolife, Inc
  • CorVocet™ Biopsy System*
  • SwiftNINJA® Steerable Microcatheter**
  • PAK™ Pedal Access Kit***
  • Advocate™ PTA Catheters
  • SPINR™ High-Performance Guidewire Controller
  • One-Step™ Centesis Catheters with Pigtail
  • Performa® Transradial Peripheral Angiographic catheter in longer lengths

Additionally, Merit team members will be available to discuss their recent transition from a distributor model to a direct sales model for Canadian customers.

* Not available in EU or CAN.
** Available in EU. Not available in US or CAN.
*** Not available in CAN.

I Am Merit: Melissa Green

I Am Merit: Melissa Green, Endotek Planning and PurchasingNearly 20 Years at Merit! In 1992 I went to work for Mallinckrodt in Angleton, TX. I was in Production working on the Performa and Trax catheters (now Merit’s Concierge Catheter). In 1998, Merit Medical acquired a small division of Mallinckrodt and that’s when my career with Merit began. We operated in the Angleton facility until 2014, and now our entire operation has been moved to a brand new facility in Pearland, TX.

When Merit acquired Mallinckrodt I moved first into a shipping/receiving role and was then promoted to Planner nearly 15 years ago.

Analyzing Data is my Passion as a Planner. I really enjoy my role as Planner. I am responsible to make sure we can meet the demands of our customers by ensuring adequate inventory of our products. I review sales orders and forecasts and compare them against worldwide inventory, and then work with Production to ensure that they’ve scheduled enough product to meet upcoming orders. If inventory is running low I notify Production and Marketing so that more product is manufactured, and I keep our customers and sales staff informed through the Customer Service teams worldwide. I love analyzing the data, working with the numbers and putting all the pieces together like a puzzle.

My New Role with Merit Endotek. Last year, I moved into a dual Planning and Purchasing role for all Merit Endotek products. So in addition to my Planning responsibilities, I ensure the availability of all raw materials needed to manufacture the Endotek products. If raw material inventory is running low in relation to customer order forecasts, I work with our vendors to order additional raw materials.

New Faces Everywhere. Merit has been a good company for me to work for. I have a great support staff and enjoy my peers and managers. When Merit first bought Mallinckrodt we were a small team. Now I see new faces everywhere. It has been fun to watch the company grow and know that I’ve played a role in all of it.

When I’m not at Work. When I’m not at Merit, I enjoy spending time with my family back in Angleton. I have two children – a daughter who is 23 and attends college and a son in high school.

I Am Merit: Esko Holt

Esko Holt, Purchasing and Planning Manager

First things first – Your Name is so Unique! Esko is a family name, it was my grandpa’s name. My grandfather was one of 13 kids. He grew up here in Richmond, Virginia next to a Russian family, and one of their children was named Esko. That’s where my great grandfather got the name for my grandfather and why my parents named me Esko.

Your Role at Merit: I have worked for Merit for 10 years. I landed here because I worked for a company called Medsource Packaging for two years and we were acquired by Merit. I took some time off and returned to Merit six months after the acquisition. I came back as a purchasing and planning agent. Ten years later I now manage the Purchasing and Planning departments.

I am responsible for scheduling all the production and for purchasing the raw materials for Richmond facility.

What happens at Merit’s Richmond Facility? Merit’s Richmond facility is responsible for custom kits, sterile medical procedure trays that carry all the tools a clinician needs to perform a specific procedure. Merit has the unique ability to customize our kits to meet our customers’ needs .

How have you seen the Merit Richmond Facility grow since you started? From the time Merit acquired Medsource through last year, sales at the Richmond facility have grown significantly. This demonstrates that the need for custom kits for physicians is obviously growing. We look at custom kits as a service provided for our customers and not just another product. It’s a service that makes their job easier by saving time and money for the clinicians.

What do you like about Merit: I really like the people at Merit, we are a family group. Everyone works well together. A lot of the employees from Medsource are still here with me for the last ten years. I really enjoy working directly with the Merit sales representatives to look for solutions for their customers.

After Work: When I’m not with my Merit family, I love to run. I’ve run several half-marathons. I’m also married with three kids: my youngest is a daughter, age 11; my middle is my son age 13; and my oldest is another daughter age 19.

Article: Transradial access for IR’s is gaining traction –An interview with three Interventional Radiologists

Interventional Radiologists interviewed about transradial access

In its November issue, Interventional News reports that transradial access for Interventional Radiologists is gaining traction, as evidenced by the full room of attendees at a satellite symposium about the radial approach, sponsored by Merit Medical during the Cardiovascular and Interventional Radiological Society of Europe’s annual meeting in September. In the article, Interventional News interviews the three symposium speakers, all interventional radiologists who are experts in the radial approach: Dr. Christoph Binkert, a professor of Radiology in Zurich, Switzerland; Dr. Aaron Fischman, an Interventional Radiologist and assistant professor of Radiology and Surgery, Mount Sinai Medical Center, New York, USA; and Dr. Darren Klass, Interventional Radiologist, Vancouver Coastal Health, Vancouver, Canada.

The three physicians outline the benefits to patients of radial artery access over transfemoral access and potential complications and data that shows a very low complication rate. They also comment on the need for radial-specific devices. In his commentary Dr. Klass discusses reasons why many interventional radiologists are hesitant to change to the radial approach and some of the reasons why these hesitations should be overcome. Finally, the article includes the top tips for starting a radial service, as provided by Dr. Klass.

Read the full Interventional News article.

Medical Design and Outsourcing features Merit Medical President and CEO Fred Lampropoulos in a Spotlight on Leadership

South Jordan Merit Medical Campus

In its January issue, Medical Design and Outsourcing features a Spotlight on Leadership by Merit Medical President and CEO Fred Lampropoulos, who describes Merit’s history of and continuous pursuit of innovation. View the full article: http://www.medicaldesignandoutsourcing.com/spotlight-on-leadership-merit-medical-continues-its-history-of-innovation/

Justin Lampropoulos: Sales & Marketer of the Year

Justin Lampropoulos Sales and Marketer of the Year

Executive Vice President of Sales and Marketing for Merit Medical Systems has been recognized by Utah Business Magazine as a Sales & Marketer of the Year.

View the video