Merit Medical EP Group Announces Launch of HeartSpan® Steerable Sheath Introducer

Merit Medical continues to add to its extensive line of products for Electrophysiology. The HeartSpan Steerable Sheath Introducer offers control, coverage and comfort for Electrophysiologists when navigating cardiac chambers. The 8.5F HeartSpan Steerable Sheath Introducer’s braided construction provides kink resistance and curve durability. The distal tapered tip creates a smooth transition from the dilator to sheath introducer to reduce trauma to the atrial septum.

CONTROL 

  • Softer, flexible tip
  • Smooth transition from dilator
  • Responsive curve deflection
  • Braided construction for kink resistance

COVERAGE 

  • Bidirectional (180-degree) deflection
  • Small curl (16.4 mm)
  • Medium curl (22.4 mm)
  • Large curl (36.0 mm)

COMFORT 

  • Ergonomic shape
  • Improved grip size

The HeartSpan line of products also includes the HeartSpan® Fixed Curve Braided Transseptal Sheath with braided steel shaft for excellent torqueability and the HeartSpan® Transseptal Needle designed to be exceptionally responsive with enhanced stiffness.

Our EP team is excited to introduce this new steerable sheath designed to help EPs extend their options.

Merit Offers Radial Internal Mammary Catheter for Navigating LIMA Grafts

Transradial cardiac catheterization in patients with previous coronary artery bypass graft surgery can be technically challenging.

Impress

Since the majority of CABG patients have a left internal mammary artery (LIMA) graft to the left anterior descending artery (LAD), many radial operators choose to perform catheterization procedures in CABG patients from a left radial approach using standard femoral diagnostic catheters. However, other operators have reported success with the right radial access to the LIMA. Right radial access for right radial LIMA angiography provides more comfortable access from the right side of the patient, reduces back strain, and the need to reach over the patient, especially patients who are obese.

For patients with LIMA grafts, Merit Medical now offers a Radial Internal Mammary catheter to facilitate navigation to the left internal mammary from the right transradial approach. The Merit Radial Internal Mammary catheter is available in 4F and 5F, 110 cm lengths. The Impress® material offers a highly torqueable shaft with a soft, tapered atraumatic tip.

Combining Merit’s broad offering of products for radial approach with your clinical expertise can help achieve the improved outcomes you expect from the radial approach including reduced complications, quicker ambulation, and increased patient comfort.

For more information about the Impress Radial Internal Mammary catheter and Merit’s growing portfolio of products for your radial procedures, visit the product page on merit.com.

Tami Anderson
Senior Product Manager

Malagari Safety and Efficacy Study of HCC TACE with HepaSphere™ Microspheres 30-60µm

Malagari photo of doc

Dr. Katerina Malagari et al conducted a study of 45 patients with hepatocellular carcinoma (HCC) treated with the new 30-60 µm size HepaSphere Microspheres. The study found that “TACE with HepaSphere was well tolerated with an acceptable safety profile and no 30-day mortality.”1 The overall objective response from the study was “(CR + PR), including patients treated at all dosages of doxorubicin, was seen in 68.9% of cases.”1 The results were published in Cardiovascular Interventional Radiology in February 2014.

HepaSphere 30–60 µm is a new size of a loadable microsphere that has a dry caliber of 30–60 µm that expands to 166–242 (197 ± 31) µm in saline and 145–213 (148 ± 45) µm after loading with doxorubicin. HepaSphere Microspheres’ unique properties offer the following advantages:

Targeted:       Flow directed due to spherical shape.

Absorbing:     Rapidly absorbs aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI.*

Conforming: Compresses in the vessel lumen, providing more surface contact with vessel intima.

Expanding:    Expands up to four times the stated dry diameter when hydrated.

HepaSphere Microspheres are indicated for use in embolisation of blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the following procedures: Embolisation of hepatocellular carcinoma and embolisation of metastases to the liver. For full prescribing information, please refer to the HepaSphere Microspheres Instructions for Use.

Antonio Rivera
Senior Product Manager
1 Malagari K, Pomoni M, Moschouris H, Kelekis A, et al. Chemoembolization of hepatocellular carcinoma with Hepasphere 30-60 . Safety and efficacy study. Cardiovasc Intervent Radiol. 2014 Feb;37:165-175.

HepaSphere Microspheres is a Class III Device, CE 0459, and manufactured for Merit Medical Systems, Inc. by Biosphere Medical, S.A., Parc des Nations-Paris Nord 2, 383 rue de la Belle Etoile, 95700 Roissy en France. HepaSphere Microspheres are not approved or available for sale in the United States.

Next Generation of the Merit Snares iPad® App Is Now Available

I am pleased to announce the availability of the next generation Merit Snares for iPad. This app is designed to help customers when selecting the appropriate EN Snare® or ONE Snare® product configuration for use in a desired vessel. The app also provides the technical product code specifications for reference and ordering purposes.

Interested in downloading Merit Snares for iPad? You can download it from the App Store via the following link: https://itunes.apple.com/us/app/merit-snares/id951074703?ls=1&mt=8

Designed with accuracy and reliability in mind, the ONE Snare and the EN Snare Endovascular Snare Systems go hand-in-hand to provide physicians with both single loop and triple loop options to help meet clinically-challenging case that may arise.

Jesse Hansen
Director of Marketing

First Patients Enrolled in the STARRT Clinical Study

DFINE® Announces First Patients Enrolled in the STARRT Clinical Study on Spinal Tumor Ablation with the STAR Tumor Ablation System

Prospective multi-center trial enrolling patients in USA

San Jose, Calif. January 23, 2015 — DFINE, Inc.,announced today that the first two patients have been enrolled in the STARRT Clinical Trial at Providence Sacred Heart Medical Center, Spokane WA. The multi-center trial is the first prospective study to evaluate the treatment of painful metastatic lesions with STAR Targeted Radiofrequency Ablation (t-RFA) and Radiofrequency Targeted Vertebral Augmentation (RF-TVA) prior to or following radiation therapy.

The principal investigator for the study, Jack Jennings, M.D., Ph.D., Director of Spine and Musculoskeletal Intervention at Washington University School of Medicine (St. Louis, MO), commented, “The protocol for this study is designed to clarify t-RFA as part of the treatment algorithm for metastatic spinal tumors and is the result of the collaboration of a multi-disciplinary working group on metastatic spine disease.”

DFINE will enroll 64 patients presenting with painful metastatic spinal lesions at up to 20 centers in the United States. The trial will evaluate the degree and durability of the palliative effect of t-RFA and vertebral augmentation combined therapy. Patients that have either failed or refuse further radiation therapy, or have yet to receive radiation therapy are eligible to be enrolled. Patients will be evaluated through a six month follow up period. The primary outcome is reduction of their pain. Secondary outcomes being evaluated are changes in quality of life, reduction of pain medications and the time to achieve adequate pain relief. Tumor control will also be evaluated.

“We’ve had very promising results with targeted radiofrequency ablation (t-RFA) to ablate localized metastatic spine tumors and augment the fractured vertebrae that is often associated with the disease. This procedure allows me to give patients rapid pain relief that dramatically improves their quality of life,” said Dr. Jayson Brower, the principal investigator at Providence Sacred Heart Medical Center where the first two patients were treated.

Cancer is a major public health problem throughout the world, and when cancer is not found early, it can metastasize (spread) to other parts of the body. A metastatic spinal tumor is a growth of cells (mass) in or around the vertebra of the spine. Over five million Americans are living with cancer that was diagnosed in the last five years and more than 1.67 million new cancer cases were expected to be diagnosed in the US in 2014 1 It is estimated that 30-40% of late-stage cancer patients will likely develop metastatic spinal tumors.2

“t-RFA and RF-TVA provide an innovative new treatment option for the many patients worldwide who suffer from the debilitating effects of metastatic spinal tumors,” said Greg Barrett, Chief Executive Officer of DFINE.

“As a company, we are committed to building a body of scientific evidence supporting the therapy and are excited to partner with several leading medical centers in the United States on this landmark trial.”

To learn more about the STARRT clinical trial, go to Clinical trials.gov/ study ID # NCT02225223.

STAR™ Tumor Ablation System

Indications for Use

The STAR Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Risks & Contraindications

Like all surgical procedures, radiofrequency ablation procedures using the STAR System involve risks, and some patients are not good candidates for the procedure. For detailed description of risks and contraindications, please review the product Instructions for Use.

Klass Doxorubicin Dose Escalation Study Examines Dose & Delivery for the Treatment of HCC

The purpose of Dr. Darren Klass, et al’s study — “The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatocellular carcinoma: a dose escalation study” — was to investigate “the relationships between dose and delivery parameters as they pertain to toxicity and response in surgically resectable hepatocellular carcinoma (HCC).”1  The study included 25 patients, randomly assigned and divided into 4 subgroups each receiving bland, 25 mg, 50 mg, 75 mg of doxorubicin-loaded HepaSphere™ Microspheres.

Klass and his colleagues published the following results:

  • 56% of patients demonstrated complete response according to EASL criteria as opposed to 0% according to RECIST (v1.0) criteria.
  • Residual tumor was identified in all groups (0 mg: 35%±28.5%; 25 mg: 42%±30.4%; 50 mg: 3.6%±3.3%; and 75 mg: 49.29%±32.6%).
  • No difference was noted between bland embolic and drug-loaded groups. Subset analysis did demonstrate a significantly increased degree of necrosis in the 50 mg-loaded group (p=0.018).
  • Strong correlation existed between arterial phase Computer Tomography EASL-based response and histopathology (r=0.81; p<0.0001).

The study concluded that “Histology correlates strongly with one-month post-procedural imaging and response optimized at 50 mg of loading per vial. Adverse events were a reflection of embolization, with no relationship between loading dose or administered dose of doxorubicin.”

Merit Medical’s HepaSphere Microspheres are indicated for use in embolization of blood vessels with or without delivery of doxorubicin HCI for therapeutic or preoperative for the embolization of hepatocellular carcinoma and embolization of metastases to the liver. For full prescribing information, please refer to the HepaSphere Microspheres Instructions for Use.

HepaSphere Microspheres offer targeted embolization that is flow directed due to their spherical shape, they rapidly absorb aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI,* and compress in the vessel lumen, providing more surface contact with vessel intima. HepaSpheres expand up to four times the stated dry diameter when hydrated. For more information on HepaSphere Microspheres, go to the HepaSphere product page or contact us.

Antonio Rivera                                                                                                                                                                                                                                                                                                                                   Senior Product Manager

 

1 Klass D, Owen D, Buczkowski A, Chung SW, Scudamore CH, Weiss AA, Yoshida EM, Ford EM, Ford JA, Ho S, Liu DM. The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatoma: a dose escalation study. Anticancer Research. 2014 Jul;34(7):3597-3606.

HepaSphere Microspheres is a Class III Device, CE 0459, and manufactured for Merit Medical Systems, Inc. by Biosphere Medical, S.A., Parc des Nations-Paris Nord 2, 383 rue de la Belle Etoile, 95700 Roissy en France. HepaSphere Microspheres are not approved or available for sale in the United States.

 

Merit Medical To Exhibit Dialysis Product Line at American Society of Diagnostic and Interventional Nephrology (ASDIN) in Orlando, February 13-15, 2015

Merit Medical is exhibiting at the 11th Annual Scientific Meeting of the American Society of Diagnostic and Interventional Nephrology in Orlando, Florida to introduce attendees to its expanding line of Hemodialysis and Peritoneal Dialysis products. The Merit Medical dialysis product suite includes the following key products:

  • The CentrosFLO® Hemodialysis Catheter, invented by Dr. Stephen Ash, was shown in a recent retrospective study to have statistically greater patency after three months due to its self-centering, curved-tip catheter which is designed to reduce thrombosis and fibrin sheath formation.1
  •  

  • The ProGuide™ Hemodialysis Catheter has a step-tip with an appositional bump design intended to reduce arterial insufficiency by keeping the tip of the catheter from sucking up against the vessel wall. The ProGuide is well known as an exchange catheter due to its easy, over the wire placement capability.
  •  

  • The Flex-Neck® line of Peritoneal Dialysis Catheters allow for up to 35% higher flow rates than other catheters currently on the US market. The Flex-Neck Classic and ARC shapes are designed to accommodate various tunneling techniques and exit site options. Our unique Implantation Systems are designed to streamline your specific implantation technique.
  •  

  • The Merit Percutaneous Implantation Kit for peritoneal dialysis (PD) catheter placement is designed to accommodate stylet or over-the-wire placement using ultrasound-guided access and fluoroscopy. To see how the kit is used, watch the PD Percutaneous Implantation Video.

Visit Merit Medical at Booth 207 to learn more about this broad line of products designed to enhance the practice of dialysis interventions and catheter placements.

Nathan Smith
Senior Product Manager
 Lynette Ruppel
Senior Product Manager

1Data on file

ONE Snare® Microsnare Sizes Approved for Sale in Europe

Merit Medical’s ONE Snare microsnare sizes are CE marked and available for sale in Europe. These new ONE Snare product configurations are available in loop diameters of 2 mm, 4 mm and 7 mm, with a 2.3F – 3F snare delivery catheter.

The ONE Snare suite of endovascular snares are now available in 15 kit configurations with 10 loop diameters ranging from 2 mm to 35 mm. These sizes complete the suite of ONE Snare product configurations and give physicians additional choices and options when foreign body manipulation or retrieval procedures arise. Designed with accuracy and reliability in mind, the ONE Snare and the EN Snare® Endovascular Snare Systems go hand-in-hand to provide physicians with both single-loop and triple-loop options to help meet any clinically-challenging case that may arise, because having options matters.

To learn more, visit the ONE Snare product webpage.

Merit Medical Showcased Products for Lead Implantation at International Symposium on Clinical Pacing in Rome

I’ve just returned from the XVI International Symposium on Progress in Clinical Pacing that was held in Rome, Italy. The symposium was a big success. Merit Medical was a sponsor of this meeting dedicated to the treatment of cardiac arrhythmias where innovation and new diagnostic and therapeutic techniques are discussed.

Dr. Seth J. Worley of Lancaster, Pennsylvania was one of the Course Directors of a half-day symposium on Interventional Device Implantation that was conducted over three sessions with Dr. Buongiorni from Pisa, Italy and Dr. Torkel Steen from Oslo, Norway as co-chairs. Some of the topics discussed were:

  • “How to Cross a Subclavian Occlusion for Venous Access”
  • “Snares for LV Lead Implantation: the most powerful technique for difficult LV lead insertion that often replaces venoplasty and anchor balloons”
  • “Interventional vs. Traditional Approach to Device Implantation”

Dr. Worley is the inventor of Merit’s Worley™ LV Delivery System. This telescoping system provides the options and tools needed to overcome the challenges of complex LV lead location and to help deliver leads, even in difficult cases. Clinical evidence has shown that a telescoping support catheter system can reduce implantation times, provide easier access to the target vessel, and improve chances for successful CRT implantation.1

To learn more about Merit’s products for CRT implantation, click on the links below.

Worley™ Advanced CSG

Worley™ Advanced LVI

Worley™ Vein Selector

Matt Toone
Marketing Director, EP

1 Jackson KP, Hegland DD, Frazier-Mills C, Piccini JP, Koontz JI, Atwater BD, Daubert JP, Worley SJ. Impact of using a telescoping-support catheter system for left ventricular lead placement on implant success and procedure time of cardiac resynchronization therapy. Pacing Clin Electrophysiol. 2013 May; 36(5):553-8.

ReSolve® Biliary Locking Drainage Catheter receives 510(k) clearance!

I am pleased to announce that the ReSolve® Biliary Locking Drainage Catheter has received 510(k) clearance and is available for sale in the US.

The ReSolve Biliary Locking Drainage Catheter has been available in Europe since July of this year and has had good success.

These catheters are indicated for drainage of bile within the biliary system. Often biliary systems need to be decompressed due to bile duct stones, extrahepatic, or intrahepatic tumors, and primary sclerosing cholangitis, among other reasons. In addition bile may also need to be diverted from a bile duct leak.

Biliary system lesions do not always occur in the same location in every patient. Because of this, Merit offers catheters with two different drainage hole configurations to accommodate patient anatomy and multiple disease locations.

Correct catheter positioning is important in these procedures. The catheter features a radiopaque marker band near the proximal shaft drainage hole, and non-radiopaque depth markers the entire length of the catheter to help with fast and accurate positioning.

Additional features:

  • Atraumatic pigtail
  • Smooth transitions
  • Large drainage holes
  • Hydrophilic coating
  • Kink resistance

To learn more, check out the ReSolve® Biliary Locking Drainage Catheter product webpage.


Richard Collard
Senior Product Manager
Merit Medical Systems, Inc.

Ostial PRO® Debuts in Turkey

Ostial PRO in Turkey

Merit Medical’s Ostial PRO Stent Positioning System was recently used for the first time in Turkey. The case was a renal aorto-ostial lesion performed by a cardiovascular surgeon at a University Hospital.

“The case went very well, and the cardiovascular surgeon liked the product very much,” Bahadir Şenol, Merit Medical Clinical Sales Specialist, said. “The surgeon plans to purchase additional Ostial PROs to have on-hand as they are needed.”

The Ostial PRO stent positioning system is an alignment tool with gold-plated “feet” that engage the aortic wall and allow easier assessment of the coronary or renal ostia, improving accuracy of stent positioning. In clinical studies, the Ostial PRO significantly increased the accuracy of aorto-ostial stent placement.1

“This is a product that can save lives,” Şenol said, adding that Merit Medical offers clinical support to doctors and hospitals that are interested in utilising the Ostial PRO. To learn more, contact your Merit Sales Representative or visit the Ostial Pro page on our website, which features a product video, several case studies, and documents such as brochures and instructions.

1 Data on file.

New Video Showcases Radial Portfolio

A new video showcases our extensive Radial portfolio, which includes products that support your radial procedure every step of the way – from preparation to hemostasis – providing procedural efficiency.  The new video highlights the benefits of radial access and includes our newest radial products, including the PreludeEASE™ Hydrophilic Sheath Introducer and the Rad Board® Radial Arm Board. To watch the new video, visit “Our Radial Products” on the Think Radial page.

Scion Clo-Sur P.A.D. to be included in Companion to Braunwald’s Heart Disease Textbook

Merit Medical was recently notified that an illustration featuring the Scion Clo-Sur P.A.D will be included in Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease, first edition by Deepak L. Bhatt MD. The book’s publication date is May 2015. Braunwald’s Heart Disease is a textbook of cardiovascular medicine. It is updated frequently to include the latest clinical trials, new research, and updates on clinical practice for practitioners, physicians-in-training, and students of cardiology. The author, Deepak L. Bhatt MD, MPH, FACC, FAHA, FSCAI, FESC is a Professor of Medicine, Harvard Medical School and Executive Director, Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center, in Boston, Massachusetts. He has authored or co-authored over 700 publications. Dr. Bhatt is the Editor of the peer-reviewed Journal of Invasive Cardiology, Chief Medical Editor of Cardiology Today’s Intervention for healthcare professionals, and Editor-in-Chief of the Harvard Heart Letter for patients.

The Clo-Sur P.A.D. is a non-woven topical pad made with a proprietary polyprolate, a positively-charged material that reacts with negatively-charged red blood cells to accelerate clotting. The Clo-Sur P.A.D. promotes hemostasis and the Clo-Sur PLUS P.A.D.™ promotes hemostasis and is indicated as an antimicrobial barrier.

The book’s illustration depicts how the Clo-Sur P.A.D.’s positive charge which reacts with negatively charged red blood cells to accelerate clotting in the tissue tract.

To learn more about the Clo-Sur P.A.D., watch the product video or Contact Us.

Mark Heninger
Senior Product Manager

ONE Snare® Endovascular Snare System Microsnare Sizes Receive FDA 510(k) Clearance

I’m pleased to announce that ONE Snare microsnare sizes are FDA 510(k) cleared and available for sale in the United States.

ONESnareThese new ONE Snare product configurations are available in loop diameters of 2 mm, 4 mm and 7 mm with a 2.3F-3F snare delivery catheter. The ONE Snare suite of endovascular snares are now available in fifteen kit configurations with ten loop diameters ranging from 2 mm to 35 mm. These sizes complete the suite of ONE Snare product configurations and give physicians additional choice and options when foreign body manipulation or retrieval procedures arise.

Designed with accuracy and reliability in mind, the ONE Snare and the EN Snare® Endovascular Snare Systems go hand-in-hand to provide physicians with both single loop and triple loop options to help meet any clinically-challenging case that may arise, because having options matters.

To learn more, visit the ONE Snare product webpage.

Jesse Hansen
Marketing Director

Merit Medical Exhibiting at 2014 VEITH Symposium in New York on November 18-22

Merit Medical is proud to support the VEITH Symposium, celebrating its 41st year, in New York City. Attendees for this meeting include vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists.

If you plan to attend VEITH, please make sure to stop by our booth to learn more about our latest innovations from access to intervention. Some of these unique devices include:

From preparation to intervention, our products are designed to help achieve the clinical, economical, and procedural efficiency that is essential for delivering the best possible care.

Look forward to seeing you at VEITH!

Jesse Hansen
Marketing Director

Merit Medical Donates PD Catheters for Stuffed Animals to Comfort Young Patients

image1-16Recently we heard from a pediatric nephrology nurse at the Johns Hopkins Children’s Center who requested a number of our pediatric Flex-Neck® peritoneal dialysis catheters on behalf of Tubie Friends™. They wanted to give their young patients a furry friend who has a PD catheter just like theirs, with hopes of making the process less frightening. We were more than willing to donate to this worthy cause.

The sales and marketing staff at Merit Medical worked together to provide the requested catheters. We were pleased to see the end result, this adorable PD Bunny pictured here. The PD nurse said the response from the patient was priceless: “It looks just like me!”

image2-18Tubie Friends is a non-profit group that was founded by two mothers of children with implanted feeding tubes. These moms wanted to make life easier for children who are receiving treatment through PD catheters or tubing.

Tubie Friends are not only donated to patients but also sold to raise funds for the organization. These comforting toys have been used as a teaching tool for family, friends, school nurses, and caregivers to help children become comfortable and less fearful of implanted tubes and catheters.

If you’d like more information about Merit Medical’s complete line of peritoneal dialysis products, please Contact Us.

Lynette Ruppel
Senior Product Manager

image3-21

HepaSphere Microspheres Absorb Both Mechanically and Ionically for Optimal Doxorubicin Loading

HepaSphere Microspheres are super absorbent polymer (SAP) microspheres made from vinyl acetate and methyl acrylate that combine to form a copolymer–sodium acrylate alcohol copolymer.

How do they work? HepaSphere Microspheres have the ability to load doxorubicin two ways: mechanically and through ionic interaction. Through mechanical interaction, HepaSphere Microspheres rapidly absorb aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI* and expand up to four times the stated dry diameter when hydrated. A recent study found that SAP have the ability to load 50 and 75 mg doxorubicin with ease of handling and optimal efficiency through dry loading.1

* Doxorubicin HCl used with HepaSphere Microspheres should be reconstituted with saline; never use pure water.

High Drug Loadability

MECHANICAL INTERACTION – HepaSphere Microspheres act as a reservoir and mechanically absorb aqueous solutions.

HepaSphere Mechanical Interaction

IONIC INTERACTION – The doxorubicin is loaded and eluted by a reversible ionic exchange mechanism.

HepaSphere Ionic Interaction

In the ionic interaction, the dry HepaSphere’s anionic polymer is negatively charged and absorbs the doxorubicin, which is positively charged or cationic.

Increased Tumour Necrosis

In a study on an animal model, the doxorubicin loading and efficiency of polyvinyl alcohol sodium acrylate copolymer microspheres were tested. The results found that Merit’s microspheres “can be efficiently loaded with doxorubicin” and that “histopathological tumour necrosis at 7 days was more prominent in the group treated with doxorubicin-loaded microspheres than in the bland embolisation group.” Both in vitro and in vivo studies showed a high drug loadability and sustained drug release over time, high intratumoural doxorubicin concentrations at each time point, and on histopathology, increased tumour necrosis.” 2

Efficient Loading

A study of doxorubicin eluting beads shows the difference in loading between HepaSphere Microspheres and another embolic brand. The study found that the competitor’s bead loaded only on the outer 20 microns of the bead. HepaSphere loads doxorubicin throughout the sphere.

HepaSphere Microspheres load doxorubicin throughout the microsphere.

HepaSphere bead

Competitor Bead – Confocal laser scanning microscopy images of dox-loaded beads (25 mgm/mL 500-700 micron bead). Image (below) shows progressive sections from the outside inwards at 10 micron intervals.3

HepaSphere bead competitor

For more information on HepaSphere Microspheres and loading of doxorubicin, explore the product’s website page or see our step-by-step reference guides:

HepaSphere Microspheres Lyophilized Doxorubicin Mixing Chart

HepaSphere Microspheres Presolubilized Doxorubicin Mixing Chart

The Merit Medical Embolics Team is ALWAYS available to answer any questions about our Embolics Portfolio. Contact Us.

Antonio Rivera, BSRT, MSHS

Global Product Manager

——————————————–

HepaSphere Microspheres are not approved or available for sale in the United States. In the European Union, HepaSphere Microspheres are indicated for use in embolisation of blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the embolisation of hepatocellular carcinoma and the embolisation of metastases to the liver.

References

  1. Liu DM, Kos S, Buczkowski A, Kee S, Munk PL, Klass D, Wasan E. Optimization of doxorubicin loading for superabsorbent polymer microspheres: in vitro analysis. Cardiovasc Intervent Radiol. 2012 Apr;35(2):391-8.
  2. Lee KH, Liapi EA, et al. Doxorubicin-loaded QuadraSphere Microspheres: Plasma pharmacokinetics and intratumoral drug concentration in an animal model of liver cancer. Cariovasc Intervent Radiol. JUN 2010; 33(3):576-582.
  3. Lewis LL, Gonzalez MV, Leppard SW, Brown JE, Stratford PW, Phillips GJ, Lloyd AW. Doxorubicin eluting beads-1: Effects of drug loading on bead characteristics and drug distribution. J Mater Sci. Sep 2007;18(9):1691-1699.

 hepasphere

 

 

Study Finds Use of Hemostasis Patch Significantly Reduces Risk of Femoral Artery Compromise in Children

closurepadCardiac Interventions News presented in its May/June issue a study at the 2014 scientific sessions of The Society for Cardiovascular Angiography and Interventions (SCAI) entitled, “Femoral Artery Compromise from Cardiac Catheterization in Children–a Multicenter Study by the CCISC (Congenital Cardiovascular Interventional Study Consortium)” by Thomas J. Forbes, MD. The study concluded that the use of a 3 Fr sheath and hemostasis patch significantly reduced the risk of femoral artery compromise. The study found that “…when a ahemostatic patch was used to seal the wound, the risk of femoral compromise was reduced by approximately two-thirds compared with manual pressure alone.”
The Scion Clo-Sur
PLUS P.A.D.™, sold by Merit Medical, is a sterile topical hemostasis pad intended for the local management of bleeding wounds, including vascular procedure sites.
To learn more about the Scion Clo-sur
PLUS P.A.D., please visit the product’s web page, or contact your Merit Medical Sales Representative.

Mark Heninger
Senior Product Manager

 

VIVA 2014 Quality Improvement Call to Action Includes Sessions on Ultrasound-Guided Vascular Access and Micropuncture Technique

One of the risks of vascular access is the inadvertent vascular puncture of the posterior wall, side branches, and veins. It can lead to increased hemorrhagic risk in anticoagulated patients, hematoma, or pseudoaneurysm. Because this is such a common problem for clinicians and their patients, this year’s VIVA (Vascular Interventional Advances) meeting is including a Quality Improvement Call to Action on ultrasound-guided vascular access that includes sessions on micropuncture technique.

Merit Medical invites VIVA attendees to visit our booth to learn more about the Merit MAK™ and S-MAK™ mini access kits designed to support micropuncture technique. These mini access kits for the percutaneous placement of 0.035″ (0.89 mm) or 0.038″ (0.97 mm) guide wires include

NEEDLE

  • 21G, smaller needle to minimize trauma and bleeding
  • 4 cm, 7cm and 9 cm lengths
  • Standard MDX coating reduces insertion force and drag
  • Echo-enhanced tip option

GUIDE WIRE

  • Stainless steel and Nitinol mandrel core wires
  • Tip options: stainless steel, platinum or palladium
  • 40 cm, 60 cm and 80 cm lengths
  • 0.018” diameter

INTRODUCER

  • Excellent transitions from dilator to introducer
  • Smooth insertion
  • 4F-5F sizes
  • 10 cm and 15 cm lengths

DILATOR

  • Excellent transitions from wire to dilator
  • MAK for all applicable vascular access sites.
  • S-MAK has a stiffened dilator for placement in scar tissue, tougher skin, calcified or diseased vessels, or obese patients.

GUIDE WIRE ALIGNMENT DEVICE

  • BowTie™ offers an elegant solution to the problem of aligning micro guide wires with devices for quick and easy insertion.

We’re looking forward to seeing you at VIVA November 4-7 at the Wynn in Las Vegas. Until then, you can find more information on Merit’s extensive line of products for vascular access on merit.com.

Chan Ream
Product Manager
Vascular Access

Merit Medical to Exhibit Dialysis Product Line at Controversies in Dialysis (CIDA) Conference in Salt Lake City, October 23-24, 2014

The world’s premier dialysis access conference is coming to Salt Lake City. We look forward to meeting the attendees who come to CIDA to discuss unique techniques and devices for hemodialysis and peritoneal dialysis access.

Merit Medical’s full suite of innovative dialysis products can help you improve your patient’s quality of life when treating end-stage renal disease (ESRD).

Our comprehensive dialysis product line features long-term hemodialysis catheters and peritoneal dialysis implantation kits, catheters, and accessories. These products are designed to meet the unique clinical needs of the ESRD patient.

For every step of your dialysis procedure, Merit Medical offers high-quality products for dialysis therapy. From preparation to intervention, our products will help you achieve the clinical, economical, and procedural efficiency that is essential for delivering the best possible care.

We look forward to seeing you at CIDA!

Nate Smith
Senior Product Manager
Hemodialysis

Lynette Ruppel
Senior Product Manager
Peritoneal Dialysis