Category: Spine

What To Expect from Merit at SIR 2022 – “Advanced Outcomes Made Simple”

Advanced Outcomes Made Simple - SIR 2022Merit will be exhibiting at SIR 2022, the Society of Interventional Radiology’s Annual Scientific Meeting. Join us June 12 – 14 in Boston, MA, for a high-quality educational program with an international audience, in-person training, and hands-on workshops. Along with showcasing an exciting lineup of leading-edge products, this year we’re hosting a Lunch & Learn session you won’t want to miss.

Here’s a sneak peek of what you can expect at booth #418:

LUNCH & LEARN

Lunch is on us! We hope to see you Monday, June 13 at 12:00 PM EDT for the following educational presentation:

Case-Based Discussion of Steerable Technology in Treatment of VCF and Spinal Metastatic Disease

DATE: Monday, June 13

TIME: 12:00 pm EDT

WHERE: Booth #418

LEARNING OBJECTIVES:

  • Understand Clinical & Procedural Value of Steerable Devices
  • Discover Therapy-Awareness Strategies
  • Engage in Case-Based Discussion and Q&A

FACULTY

J. Dana Dunleavy - Think Spine Proctor

Dana Dunleavy, M.D.
Windsong Radiology Director of Interventional & Vascular Services
Buffalo, NY
Learn more about Dr. Dunleavy

PRODUCT SHOWCASE AT BOOTH #418

NEW Prelude Roadster™ Guide Sheath

Prelude Roadster

Expand your diagnostic and interventional procedures with the new Prelude Roadster, a longer guide sheath designed to access difficult anatomy in the peripheral vasculature. Stop by booth #418 to be among the first to discover this brand-new technology.

ReSolve® Thoracostomy Tray

ReSolve Thoracostomy Tray - Merit Medical

The ReSolve Thoracostomy Tray allows air (pneumothorax) and fluid (pleural effusion) to be drained from the pleural space through a percutaneous approach rather than an open surgical approach, providing your patients with minimally invasive care.

TEMNO Elite™ Biopsy System

Sample Assist - Biopsy Samples with the Push of a Button - TEMNO Elite Biopsy System - Merit Medical

The TEMNO Elite Biopsy System offers the reliability you expect with new features designed to provide superior soft tissue samples and total procedure control.

SplashWire™ Hydrophilic Steerable Guide Wire

SplashWire - REIMAGINE YOUR GUIDE WIRE

The Merit SplashWire combines optimum lubricity, exceptional torque response, and enhanced visibility, helping you achieve the successful outcomes you expect for your patients. We designed the SplashWire to successfully perform in the most complex cases.

ReSolve ConvertX® Nephroureteral & Biliary Stent System

ReSolve ConvertX - Ureteral or Biliary Obstructions

Drain to stent in 30 seconds1 with the ConvertX. Designed to treat ureteral and biliary obstructions, you can place it like any internal-external drain, then convert it to a stent when you’re ready.

Surfacer® Inside-Out® Access Catheter System

Surfacer® Inside-Out Access system - Restore Access, Preserve Options - Merit Medical

Pioneered by interventional cardiologist John Gurley, M.D., the Inside-Out approach was developed in response to patients with chronically occluded veins that required life-saving vascular access. Inserted in the femoral vein, the Surfacer Inside-Out Access Catheter System locates an exit from the right internal jugular vein, maintaining viable secondary veins if necessary.

See the Surfacer featured on the cover of June 2022 Journal of Vascular Surgery.

One-Vac™ Evacuated Drainage Bottle

One-Vac Evacuated Drainage Bottle

Engineered with an advanced design, the One-Vac is the smart option when choosing an evacuated drainage bottle. Built with a number of key features, the One-Vac makes percutaneous fluid collection and discard simple, efficient, and safe for you and your patients.

EmboCube® Embolization Gelatin

EmboCube Embolization Gelatin

Specifically designed for embolization of hypervascular tumors and blood vessels to occlude blood flow, EmboCube controls hemorrhaging in the peripheral vasculature. Gelatin is cut uniformly in preloaded 1-mL or 3-mL Medallion® Syringes to help ensure seamless prep and accurate delivery.

Embosphere® Microspheres

The most clinically studied spherical embolic, Embosphere is the clear choice among interventional radiologists. Designed for predictable and durable occlusion for the embolization of symptomatic uterine fibroids, AVMs, and hypervascular tumors, the elastic material allows for temporary compression of up to 33%3, yielding targeted results for patients and practitioners.

Merit Maestro® Microcatheters

Maestro Microcatheter - Embolotherapy Delivery System

A multipurpose microcatheter, the Maestro is designed to deploy coils up to 0.018″ and embolics up to and including 900 µm. A swan neck design helps you seat the catheter in the vessel, reducing the recoiling effect.

SwiftNINJA® Steerable Microcatheter

SwiftNINJAfull_coiled-sm

The SwiftNINJA is an innovative straight-tip catheter featuring an ergonomic steering dial that navigates up to 180 degrees and enables in vivo control. Consisting of a hydrophilic-coated distal 80 cm, the device delivers exceptional precision and speed even when you’re navigating the most challenging vascular ostium.

Prelude IDeal™ Hydrophilic Sheath Introducer

Prelude IDeal Sheath Introducer - Merit Medical

A hydrophilic access sheath with increased kink and compression resistance makes the IDeal the tool of choice for your radial access procedures.

Arcadia™ Steerable Balloon-Assisted Vertebral Augmentation

Arcadia Steerable Balloon-Assisted Vertebral Augmentation

The Arcadia is designed to achieve controlled, precise, targeted cavity creation in your vertebral augmentation procedures—whether your approach is unipedicular or bipedicular.

NEW AT MERIT: Arcadia™ Curved Delivery Cannula

Arcadia Curved Delivery Cannula - VCF

Stop by booth #418 and ask us about our NEW Arcadia™ Curved Delivery Cannula—a bone cement delivery system designed for predicable cement deposition across the midline of the vertebral body, optimizing cement volume, while potentially reducing the need for bipedicular access.

STAR™ Tumor Ablation System

STAR Tumor Ablation - Radiofrequency Ablation - Merit Medical

STAR delivers meaningful pain relief and localized tumor destruction in a single treatment. Your patients will appreciate that this mechanism is designed to perform successfully and comfortably in an outpatient setting.


We look forward to seeing you at SIR 2022 and discussing all the ways we can help you enhance your patient care. Questions? Contact our Customer Support team and speak to one of our representatives. Live chat, phone, or email—we are here for you.

Don’t forget to follow us on social media for live conference updates!


Before using any of the Merit products mentioned above, refer to Instructions for Use for indications, contraindications, warnings, precautions, and directions for use.

REFERENCES

  1. Data on File.
  2. Laurent et al. Am J Neuroradial 1996.

Breaking Down Osteoporosis with Dr. Altin Stafa

Altin Stafa, MD - NeuroradiologistSuffering a broken hip may seem somewhat common for aging adults, but it can actually be a warning sign for a serious medical condition called osteoporosis, affecting 1 in 5 women over 50. May is Osteoporosis Month, and to gain an understanding of how the disease is prevented and treated, we spoke with Altin Stafa, MD, neuroradiologist at Ca’ Foncello Hospital of Treviso (Italy).

What is osteoporosis, and who is most at risk?

Osteoporosis is a bone disease that develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes, decreasing bone strength and increasing the risk of fractures or broken bones.

Some consider osteoporosis a “silent” disease, because people with osteoporosis typically do not learn of their diagnosis until first breaking a bone. Fractures can occur in any bone but are most common in bones of the hip, wrist, and vertebrae in the spine.

“Osteoporosis mainly affects women at menopause when levels of bone-bolstering estrogen fall rapidly,” Dr. Stafa explains. “However, it should not be forgotten that men of the same age, even though much less frequently, can also suffer from osteoporosis. In addition, pathological conditions, such as hyperparathyroidism and chronic kidney disease, can cause gender-independent osteoporosis even at a younger age.”

If a parent experiences a broken hip or other broken bone, one may be at higher risk and should discuss with a doctor if screening for osteoporosis is recommended.

What types of fractures are most common among patients with osteoporosis?

Spinal Fractures L1 & L2Fractures are often the first sign of the disease for people living with osteoporosis, and vertebral fractures are among the most frequent type. Why does this happen? “The static and dynamic load which the spine is subjected to is much higher than the one of other bone segments. The spinal segment most frequently affected by compression fractures is the lumbar one, in the lower back region, due to its higher static and dynamic load. Also, the last two thoracic vertebrae, in the mid-back region, are frequently a fracture target because of higher dynamic load, consequent to spinal torsion, flexion, and extension,” Dr. Stafa clarifies.

For some patients with more severe osteoporosis, Dr. Stafa shares that “the mid thoracic vertebrae can also fracture.” He advises giving special attention to the sacrum, that sits below the lumbar vertebrae, which frequently has underdiagnosed fractures. “Compression fractures of the cervical spine in the neck region and of the upper thoracic region are rare,” Dr. Stafa adds.

How are fractures diagnosed and treated?

People experiencing significant, sudden, localized back pain that interferes with daily life should consider seeking medical expertise to evaluate their spine for possible diagnosis of a vertebral fracture. “Even when they are not painful, osteoporotic vertebral fractures may cause a gradual and severe reduction of the vertebral body height, which can negatively impact the biodynamics of the whole spine, causing spinal deformity (i.e., kyphosis), chronic back pain, consequent chest and abdominal space reduction with overall negative impact on the patient’s quality of life,” Dr. Stafa explains.

A number of treatments are available for patients with fractures, according to Dr. Stafa. “Vertebral compression fracture treatments include pain medication, bed rest, and bracing as well as physiotherapy. Although these approaches may help some patients, most of them have found little to no relief or clinical improvement.”

What is vertebral augmentation treatment?

“People with serious pain from fractures may benefit from vertebral augmentation. This minimally invasive procedure has provided substantial, immediate pain relief while reducing progressive vertebral body height reduction and consequent spinal deformity,” Dr. Stafa explains. Vertebral augmentation involves one or two very small incisions in the skin (less than 1 cm in length) to access the vertebral body affected by the fracture, creating channels or cavities inside the vertebral body, and delivering bone cement to stabilize the fracture.

Merit has designed cutting-edge vertebral augmentation products for physicians that address patient-specific needs when treating vertebral compression fractures. “Good clinical outcomes are a result of the ability to control the size, shape, and location of channels and cavities in the vertebrae, using steerable devices, to allow for optimal amount and location of cement, to stabilize the fracture,” Dr. Stafa shares.

Merit Medical is dedicated to collaborating with physicians to innovate the tools needed to help create a better quality of life for people living with osteoporosis. Learn more about our Spine portfolio of diagnostic and interventional products that target spine pathology and reduce pain with minimally invasive precision. Contact our Customer Support Center to learn how you can implement these and more into your practice.


References:

  1. Centers for Disease Control and Prevention. 2022. “Does Osteoporosis Run in Your Family?” https://www.cdc.gov/genomics/disease/osteoporosis.htm
  2. National Institutes of Health. 2022. “Osteoporosis Overview.” https://www.bones.nih.gov/health-info/bone/osteoporosis/overview

What’s Your Clinical Challenge? We Have a Solution.

As a leader in customer-focused healthcare, Merit Medical’s priority is to ensure that you have the tools you need to care for your patients. Ranging from product kits to education opportunities, our Complete Solutions simplify preparation and streamline procedures to support quality patient care with a trusted, innovative range of medical devices.


BIOPSY

Biopsy Solution

We offer a wide range of reliable biopsy devices for precise samples every time. Our proven soft tissue biopsy brands, such as Achieve®, Temno®, Tru-Cut®, and CorVocet®, offer a complete selection with advanced features to obtain top-quality tissue samples with ease and efficiency.

LEARN MORE >

CARDIAC CATHETERIZATION

Our cardiac catheterization solutions provide you with a variety of tools to help you accurately diagnose and successfully treat patients with heart problems. From sheath introducers, like our Prelude IDeal™, and guide wires to catheters, inflation devices, and more, we offer a number of superior devices for your procedures.

LEARN MORE >

CRITICAL CARE

Critical Care Solutions

When treating vulnerable patients, every product you use matters. We offer a broad spectrum of tools designed for patients being treated in the critical care unit. Merit critical care technologies aim to reduce contaminant exposure, accurately monitor patient blood pressure, and decrease workplace injury, helping you provide treatment that is safe, effective, and efficient.

LEARN MORE >

DIALYSIS ACCESS

Dialysis Access Solution

Kidney disease is a global issue, and access is the foundation for any successful dialysis procedure. Our comprehensive dialysis access portfolio, including our catheter-dependence reducing HeRO® Graft, brings reliable and innovative solutions to your practice.

LEARN MORE >

PERITONEAL DIALYSIS

Our home dialysis options offer several patient advantages over in-center dialysis, including better kidney disease-related quality of life. We offer virtual and hands-on physician training, a wide range of catheter sizes, accessories, kits, and patient resources.

LEARN MORE >

RADIAL

Radial access has many well-documented benefits that include improved patient safety, a significant reduction in cost of care, and increased patient and staff satisfaction. We support radial access with a diverse portfolio of innovative products and a world-renowned hands-on physician education program, helping you offer the advantages of radial to your patients.

LEARN MORE >

DISTAL RADIAL ACCESS

Distal radial artery access offers both patient and operator advantages. To help bring these benefits to your practice, we provide advanced training on the distal technique as well as innovative products to support your procedures, such as the first-to-market PreludeSYNC DISTAL™ Radial Compression Device.

LEARN MORE >

DRAINAGE

Over the past two decades, we have continually expanded our drainage portfolio to include a diverse range of solutions that work together to help you achieve optimal drainage care. We offer multiple drainage catheters designed to lessen trauma and promote a more accurate placement.

LEARN MORE >

ELECTROPHYSIOLOGY & CRM

Successful diagnosis and treatment of electrical cardiac activity is crucial—this is why we offer a range of physician education courses and specialized tools to assist in making accurate diagnoses and create effective treatment plans. Features include extra-stiff transseptal needles, ergonomic handles for exceptional control, and advanced introducer systems.

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EMBOLOTHERAPY

Our proprietary embolic products are the most studied on the market and allow for efficient and safe delivery and predictable outcomes. To complement our offerings, we provide excellent ongoing customer service to ensure you have the tools you need for your procedures.

PROSTATIC ARTERY EMBOLIZATION
To help support your prostatic artery embolization (PAE) practice, we offer virtual and hands-on training, trusted products, clinical resources, patient materials, and more.


UTERINE FIBROID EMBOLIZATION
Our uterine fibroid embolization (UFE) solutions offer trusted products that deliver predictable clinical results as well as long-term symptom control.


We also offer extensive patient resources at our Ask4PAE and Ask4UFE sites.

LEARN MORE >

GASTROENTEROLOGY STRICTURE MANAGEMENT

GI Stricture Management

Merit Endoscopy’s fully covered, laser-cut esophageal stent technology provides for accurate placement and minimized migration. In addition to our state-of-the-art stent technology, we deliver best-in-class dilation products, including our BIG60® Inflation Device and our Elation dilation balloons as well as enhanced physician training.

LEARN MORE >

PULMONARY STRICTURE MANAGEMENT

For patients with tracheobronchial strictures, stent technology can provide rapid palliation and improve quality of life. We offer fully covered, laser-cut tracheobronchial stents and advanced over-the-wire and direct visualization delivery systems. Download case studies and participate in virtual and hands-on training—all designed to help you advance patient care.

LEARN MORE >

KITS & PACKS

Designed to bring convenience and efficiency to your office, our kits and packs solutions can help simplify prep and procedure, support quality patient care, and reduce inventory levels. Our team analyzed hundreds of kits and created a set of standard configurations that meet the needs of the majority of cath labs, interventional radiology, and vascular surgery departments. We also offer customizable kits to fit your unique procedural needs.

LEARN MORE >

SPINE

Through a diverse portfolio of sophisticated steerable technologies, we deliver complete procedural solutions designed to treat pathologies of the vertebrae, reduce pain, and improve patient quality of life. Our comprehensive education programs and unique products allow physicians to address patient-specific needs and physician preference in the treatment of vertebral pathologies.

LEARN MORE >

VENOUS

Venous Solutions from Merit Medical

Our minimally invasive venous solutions are designed to treat symptoms, minimize post-operative pain, and provide faster recovery. Explore products, accessories, and kits, packs, and trays—each complementing the next to provide you with better patient outcomes.

LEARN MORE >


Merit’s dedication to comprehensive customer care starts with providing the tools you need to treat your patients. Ready to get started? Available via email, phone, and live chat, our Customer Support team is here to help find a solution for you. Browse our virtual in-service and product support videos, all designed to help you obtain additional product knowledge and insights. We look forward to working with you.

Merit Recognizes National Osteoporosis Month

May is National Osteoporosis MonthMay is National Osteoporosis Month, an important time we recognize at Merit Medical. Although honored in the US, osteoporosis is a global issue. Osteoporosis causes bones to weaken, and recent statistics show that worldwide, 1 in 3 women and 1 in 5 men over the age of 50 years will experience osteoporotic fractures in their lifetime.

Vertebral compression fractures, or VCFs, are the most common osteoporotic fracture—almost twice as common as other fractures caused by osteoporosis. Osteoporotic fractures can lead to long-term pain and even be life threatening.

1 in 3 Women & 1 in 5 Men Over 50 Years Old

To help care for this patient population, we provide a wide range of innovative tools for vertebral augmentation (kyphoplasty) and vertebroplasty treatments.

Listen in as Mrs. Steiner, a patient who suffered from a painful VCF, explains in her own words how treatment with Merit’s steerable Arcadia™ Balloon-Assisted Vertebral Augmentation System helped her resume an active lifestyle.

Browse helpful osteoporosis month resources:



Before using any of the Merit products mentioned above, refer to Instructions for Use for indications, contraindications, warnings, precautions, and directions for use.

SwiftNINJA® Overcomes Challenges of Selective Catheterization

SwiftNINJA Steerable Tip - Merit Medical

Selective catheterization can be associated with several challenges, such as acute angle branching, blood vessel tortuosity, and small targeted vessel diameter.1 The SwiftNINJA Steerable Microcatheter by Merit Medical, a straight tip catheter that articulates up to 180 degrees in opposing directions, is designed to rapidly select challenging vascular ostium.

case report by Soyama et al.1 found multiple benefits to using the SwiftNINJA in catheterizations involving acute angle branches as well as a new technique of intentional folding of embolization coils for compact coil packing. The authors found that using a steerable microcatheter made the procedure easier compared to using a conventional device.

The study, published in CardioVascular and Interventional Radiology,1  discussed the following two cases:


CASE 1: CATHETERIZATION OF ACUTE ANGLE BRANCHES

A male patient in his 60s presented with an angiomyolipoma of the left kidney. CT images showed an 8-cm tumor of the left kidney, which had enlarged. To prevent tumor rupture, transcatheter arterial embolization was conducted.

Using the Seldinger technique, a 5F J-shaped sheath introducer was placed percutaneously into the aorta via the left femoral artery. Selective left renal arteriography was performed with a 4F cobra-shaped catheter.

The arteriogram showed two arterial branches of the superior renal capsular artery supplying the primary blood flow to the tumor, both branching out from the main left renal artery with an acute angle of origin. Due to the acute angle branching, Soyama and his team were unable to selectively insert a manually tip-shaped guide wire and instead used the SwiftNINJA as follows:

STEP 1: 
Bent the tip to turn the orifice of the targeted branch by dial manipulation at the proximal handgrip. Fixed the shape of the tip with the dial stopper.

STEP 2: 
Inserted a 0.016-in guide wire into the targeted branch.

STEP 3: 
Unlocked the dial stopper. Pushed the microcatheter deep into the targeted branch using the over-the-wire method.

RESULTS: 
Catheterization of two targeted branches was completed within 3 minutes. Successful embolization of the target branches followed.

CASE 2: INTENTIONAL FOLDING OF METALLIC COILS IN THE BLOOD VESSEL

A male patient in his 60s presented with right maxillary cancer and was admitted for transcatheter arterial infusion chemotherapy combined with irradiation.

A 5F sheath introducer was percutaneously placed into the aorta via the right femoral artery followed by selective insertion of a 5F catheter into the right common carotid artery. The SwiftNINJA was then inserted into the right internal and external carotid artery.

Selective angiogram showed the targeted tumor was being supplied by the right internal maxillary artery, the transverse facial artery, and the facial artery. It was embolized with pushable metal coils with the intention of creating compact packing of the coils to strengthen the embolic effect and prevent reperfusion:

STEP 1:
Bent the tip of the SwiftNINJA inside the blood vessel using the proximal dial, maintained tip shape, and slowly pushed the coil. The coil was intentionally folded by the change in tip direction. Compact packing was achieved.

STEP 2:
Pushed the second coil into the targeted blood vessel in the same way, completing the embolization using compact coil packing of the right superficial temporal artery.

In procedures such as these, selective catheterization can be very difficult, in some cases forcing a physician to abandon the catheterization all together—even if the shape of the guide wire and catheter was chosen to fit a desired vessel branch.1

In contrast, the SwiftNINJA “has the potential to make selective catheterization easier than when using the conventional device, due to the ability to control the tip shape,” the authors write.1

In the first case,1  the SwiftNINJA allowed the user to shape the tip to the targeted branches easily and properly when needed. It could also be manipulated during catheterization without removing it to reshape the tip, which the authors said could potentially make selective catheterization easier.

The authors1  suggested that in the second case, the SwiftNINJA could be useful for both selective catheterization and compact packing of metallic coils where adjusting and maintaining microcatheter tip shape can be a challenge. Using a steerable microcatheter, they write, “enables the user to easily create an initial loop of the inserted coil and intentionally fold the coils with the stiffly bent catheter tip.”

Soyama et al.1  concluded that the SwiftNINJA “has the potential . . . to allow difficult catheterizations to be completed more easily.”1


SWIFTNINJA KEY FEATURES

SwiftNINJA Steerable Microcatheter

Several features and benefits enable the SwiftNINJA to be the solution needed during challenging interventional procedures:180-Degree Steerable Tip The SwiftNINJA’s steerable tip provides speed, navigation, and support—even in the most challenging vascular anatomy. An ergonomic steering dial enables the catheter tip to be deflected from straight to opposing directions up to 180 degrees, allowing for in vivo steering control.
Steering Lock Once the SwiftNINJA’s tip is positioned at a desired location, it can be locked to hold the shape of that position. The tip will remain positioned for embolic placement without the worry of recoil, loss of position, or embolic displacement.
Multi-Dimensional Steering Once the catheter is shaped into a desired position, the SwiftNINJA can then be torqued and advanced through the vasculature, providing 3D steering as it moves in two planes simultaneously.
Tungsten-Braided Shaft Built with a tungsten-braided shaft, the SwiftNINJA provides support and pushability when navigating tortuous vasculature.
Cost Efficiency Because the SwiftNINJA can navigate through complex blood vessels and reach target anatomy quickly, it can be a cost-effective option compared to failed attempts using numerous catheters. As mentioned by Soyama et al.,1  the SwiftNINJA made their procedure easier to perform than using a conventional device.

Similarly, another case study by Hinrichs et al.2 described successful coil embolization of a small hepatointestinal collateral with the SwiftNINJA after failed attempts with other catheters. Henrichs et al.2 write, “taking into account the numerous regular microcatheters that were used without success in our two cases, the appropriate use of a steerable microcatheter can be even more cost-effective with regard to the total material costs.” Merit Medical is committed to providing the medical devices needed to improve and transform healthcare. Discover the SwiftNINJA Steerable Microcatheter by visiting the product page and the Merit Medical Customer Support Center for more information.



References

  1. Soyama et al. 2017. “The Steerable Microcatheter: A New Device for Selective Catheterization,” CardioVascular and Interventional Radiology 40, no. 6: 947-952, PMID: 28138724.
  2. Hinrichs et al. 2017. “Coil Embolization of Reversed-Curve Hepatointestinal Collaterals in Radioembolization: Potential Solutions for a Challenging Task,” Radiology Case Reports 12, no. 3: 529-533, PMID: 28828119.

Arcadia™ Steerable Technology Provides Unique Benefits to Vertebral Augmentation Treatment

Vertebral compression fractures (VCFs) are the most common fracture in patients with osteoporosis.1 Although painful and debilitating, VCFs often go untreated. To help care for this patient population, Merit Medical innovated the Arcadia, an intuitive balloon-assisted vertebral augmentation (kyphoplasty) system. Designed to be used with the steerable PowerCURVE® Navigating Osteotome, the Arcadia offers several unique benefits when treating patients with painful VCFs.

Bipedicular Footprint, Unipedicular Approach

Arcadia Steerable Technology - Merit Medical

Steerability allows the Arcadia system to target a specific location within the vertebra using a transpedicular approach through a single skin incision. Once past the pedicle body junction, the ability to articulate the device allows accurate navigation to the biomechanically critical important anterior and middle third of the vertebra, resulting in a bipedicular cement footprint byway of a less invasive unipedicular approach.

Unipedicular access has other clinical advantages as well. A systematic review and meta-analysis published in Pain Physician2 compared the safety and efficacy of unipedicular and bipedicular vertebral augmentation approaches in the treatment of osteoporotic VCFs. Results showed that the unipedicular approach required less procedural time, lower radiation dose, and a reduced cement leakage ratio with similar clinical outcomes in pain relief, decreased disability, and improved short and long-term general health.

Reduced Procedural Radiation Exposure

Reduced Radiation Exposure - Merit Medical

The use of fluoroscopic guidance in the transpedicular treatment of VCFs is necessary for visualization; however, radiation exposure must be limited when possible. The single access unipedicular approach, as provided with the steerable Arcadia, has the potential to reduce radiation exposure.2 Radiation exposure to patients undergoing unilateral vertebral augmentation has been shown to be 50% of the dose received by patients who receive bilateral treatment.2

Safe Transpedicular Access

Compassionate and Safe - Merit Medical

Transpedicular steerable access, as made possible with the Arcadia and the PowerCURVE, is intended to enable safe passage past the pedicle body junction into the vertebral body. This approach offers advantages, including avoidance of the radicular spinal arteries, which are vulnerable when using an extrapedicular approach. This is significant given spinal arteries, such as the artery of Adamkiewicz, usually arise from the level of the ninth intercostal artery to the second lumbar artery.3

Further, Liu et al. reported that extrapedicular vertebral augmentation in the lumbar vertebrae had a risk of injuring the lumbar artery and was not recommended for use in L4 and L5, especially in female patients.4 Given this data and the size of lumbar vertebrae, transpedicular access with the steerable Arcadia and PowerCURVE devices may be an appropriate treatment option for this patient population.

Transpedicular access through the pedicle using steerable devices also reduces the oblique angle required when using rigid straight devices, decreasing the risk of breaching the medial cortex and cement leakage within the spinal canal.5

Enhanced Navigation

Enhanced Navigation - Merit Medical

Compared to curved devices manufactured with a predetermined shape which limits trajectory based solely on access into the vertebral body, steerability allows physicians to change trajectory simply by turning the gray handle of the PowerCURVE and Arcadia after accessing the vertebra.

This provides a targeted single-access ability to cross the vertebral midline, enabling optimal balloon tamp positioning and cavity creation. The steerable osteotome, when used alone, can provide targeted channel creation, simultaneously sparing healthy cancellous bone and maximizing surface area to facilitate cement interdigitation. In addition, targeted cavity creation supports the controlled delivery of high-viscosity cement with optimal cement fill.

Reduced Complications

The sophisticated steerable technology of the Arcadia system enables a unipedicular approach to treatment. Complications associated with vertebral augmentation, in general, include infection, neural damage, and pedicle fracture.6 Passing the spinal canal only once, as seen with a unipedicular approach, may reduce the occurrence of such complications.

The Arcadia Balloon-Assisted Vertebral Augmentation System is a prime example of the new technologies Merit provides physicians, helping them to improve procedural outcomes and better the patient experience.

Indication for Use: The Arcadia steerable and straight balloon catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. These balloon catheters are to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement for use during percutaneous vertebral augmentation, such as kyphoplasty.

Explore the Arcadia by visiting its product page or through the Merit Customer Support Center.


References

  1. Pilitsis JG. n.d. “Vertebral Compression Fractures.” https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Vertebral-Compression-Fractures.
  2. Sun H et al. 2016. “Can Unilateral Kyphoplasty Replace Bilateral Kyphoplasty in Treatment of Osteoporotic Vertebral Compression Fractures? A Systematic Review and Meta-Analysis.” Pain Physician 19, no. 8 (Nov–Dec): 551–563. PMID: 27906934.
  3. Kudo K et al. 2003. “Anterior Spinal Artery and Artery of Adamkiewicz Detected by Using Multi-Detector Row CT.” American Journal of Neuroradiology 24(1): 13–17. PMID: 12533320.
  4. Liu L et al. 2019. “An Anatomical study on lumbar arteries related to the extrapedicular approach applied during lumbar PVP (PKP).” PLoS One 14, no. 3: e0213164. PMID: 30835754.
  5. Chung HJ et al. 2008. “Comparative Study of Balloon Kyphoplasty with Unilateral Versus Bilateral Approach in Osteoporotic Vertebral Fractures.” Int Orthop 32, no. 6 (Dec): 817–820. PMID: 17768624.
  6. Tsoumakidou G et al. 2017. “CIRSE Guidelines on Percutaneous Vertebral Augmentation.” Cardiovascular and Interventional Radiology 40(3): 331–342. PMID: 28105496.

StabiliT® MX Vertebral Augmentation System Brings Steerability, Dexterity, and Control to Vertebral Augmentation Procedures

StabiliT MX Vertebral Augmentation System - Steerability, Dexterity, Control - Merit Medical

Merit Medical is committed to providing physicians with the vertebral augmentation tools needed to treat vertebral compression fractures. The StabiliT® MX Vertebral Augmentation System assembles a variety of vertebral augmentation products into one convenient kit, each working together to create preferential paths for the controlled delivery of high-viscosity bone cement in variety of fracture morphologies. Providing a targeted, bone sparing vertebral augmentation solution.

StabiliT MX Vertebral Augmentation System contents include the PowerCURVE Navigating Osteotome, DiamondTOUCH Syringe, StabiliT Bone Cement, and more. With these components, the StabiliT MX Vertebral Augmentation System brings steerability, dexterity, and control to vertebral augmentation procedures.

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Steerability

The PowerCURVE Navigating Osteotome provides steerable channel creation to the entire vertebral body via a unipedicular access.1 While preserving intact cancellous bone and maximizing cement interdigitation.3,4 With the PowerCURVE, vertebral stabilization is achieved by creating preferential paths for a targeted cement fill.2

Learn more about PowerCURVE key steerability features.
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Dexterity

The DiamondTOUCH combines the visibility and accuracy of a digital gauge with the dexterity of the clutch mechanism. Its bright LCD gauge is highly visible with easy-to-read numbers, and its clutch mechanism enables immediate cement flow stoppage if needed, delivering the performance that meets the multiple demands of vertebral augmentation procedures. The 36-inch delivery line allows operation of the syringe away from the radiation source.

Explore how the DiamondTOUCH can enhance the dexterity of your vertebral augmentation procedures.
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Control

The StabiliT MX Vertebral Augmentation System provides StabiliT Bone Cement, our patented high viscosity cement with an extended 35-minute working time. The StabiliT Bone Cement provides controlled delivery and procedural flexibility.

Discover how StabiliT Bone Cement can benefit your vertebral augmentation procedures.
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Find what you need for your vertebral augmentation procedures in the StabiliT MX Vertebral Augmentation System, and learn about all the ways we support minimally invasive treatment of vertebral compression fractures.

REFERENCES

  1. Hillen TJ, Radiology, 2014 v273 p261–7 PMID: 24927328
  2. Rahel Bornemann, Pain Physician: September/October 2013; PMID: 28323707
  3. Bassem Georgy, Pain Physician. 2013 Sep–Oct;16(5):E513–8; PMID: 24077201
  4. Dalton BE, Clin Interv Aging, 2012;7:525–31; PMID: 23204845

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Treating Vertebral Compression Fractures with Multiple Therapeutic Options

Think VCF Solutions - Treat VCF with Multiple Therapeutic Options - Merit Medical

Merit Medical provides physicians with a wide range of vertebroplasty and vertebral augmentation tools, offering patients various pathways to treatment.

Vertebral compression fractures (VCFs) can have debilitating effects on a patient’s quality of life. Our goal at Merit Medical is to provide physicians with a broad range of tools to treat VCFs through minimally invasive vertebroplasty and vertebral augmentation (kyphoplasty) procedures. Through our full family of VCF solutions, physicians can target fractures by finding the right therapeutic approach that meets the needs of each patient.

Our extensive VCF portfolio offers options that include balloon and non-balloon products, devices that provide a unipedicular or bipedicular approach, straight and steerable cavity creation tools, high-viscosity cement, and the products to deliver it with control and precision.

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StabiliT® Vertebral Augmentation System

Treat pathological fractures and minimize extravasation in the vertebrae with a targeted approach that uses RF energy-treated, high-viscosity cement with a 35-minute extended working time and remotely controlled delivery.
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StabiliT MX Vertebral Augmentation System

Take advantage of the same high-viscosity bone cement with a 35-minute extended working time but without the need for capital equipment. The StabiliT MX allows you to deliver cement using a precision syringe that allows for immediate cement flow stoppage.
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StabiliT VP Vertebroplasty System

Enjoy simple prep of high-viscosity bone cement without blending or stirring and with no need to transfer cement. The StabiliT VP offers controlled cement delivery with the same 35-minute extended working time.

Learn more about StabiliT Bone Cement in Merit’s Latest News.
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StabiliT Introducer

Achieve percutaneous access to bone during vertebroplasty and vertebral augmentation procedures with the StabiliT Introducer. Optimized radiolucency minimizes imaging obstruction while an ergonomic handle and depth markers on the cannula shaft assist with intraoperative manipulation and positioning.
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Osseoflex® SB Steerable and Straight Balloons

Utilize a unipedicular or bipedicular approach to vertebral augmentation. The Osseoflex SB treats VCFs by compacting cancellous bone for controlled and precise cavity creation followed by predictable cement delivery.
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Osseoflex SN Steerable Needle

Get direct access to the entire vertebral body through a unipedicular approach to vertebral augmentation. The Osseoflex SN delivers single-channel or multiple-channel cavity creation by steering and articulating to achieve targeted bone disruption.
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Osseoflex Access Instruments

Find a simple solution to percutaneous bone access for vertebral augmentation with the Osseoflex. Access instruments can be used with other products to deliver bone cement to a vertebral body for treatment of VCFs. Both diamond and bevel tip stylets are included for physician choice.
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DiamondTOUCH Syringe

Combine visibility and accuracy of a high-resolution digital device with the convenience of an ergonomic one-handed prep handle in this 30-mL syringe. The DiamondTOUCH is intended for bone cement delivery, inflation and deflation of interventional devices, and to monitor pressure (up to 35 ATM, 500 psi).
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Merit Medical offers a diverse portfolio of VCF solutions, so you can choose the right tools for your procedures. Discover how we support minimally invasive vertebroplasty and vertebral augmentation by visiting our VCF solutions page and learning about our many versatile products.
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Updated Spine Resources for Your Practice

Spine Resource Center - Merit medical

Merit Medical has recently updated its online Spine Resource Center as a way to support you in your spine practice as well as to help provide the best possible outcomes for patients undergoing vertebral augmentation (kyphoplasty), vertebroplasty, and spinal tumor ablation treatments. By inserting your email address, you’ll have access to a wide range of valuable tools and helpful information available for download.

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Patient Education

Educate patients and increase awareness about interventional spine procedures with both digital and printed resources.

Digital Patient Resources
Use Merit’s digital tools on your practice website and social media as well as to boost your overall patient education efforts. With a licensing agreement, you’ll have access to treatment-related text, illustrations, and videos.

Printed Patient Resources
Order printed patient collateral, such as informational brochures and other patient awareness materials, simply by filling out an order form. The materials will be shipped to you at no cost.
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Referring Physician Education

Collaborate with fellow physicians using Merit’s peer-to-peer presentations that address important topics, including patient selection, clinical evidence supporting interventional spine procedures, and more.
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Clinical Resources

Throughout your day-to-day, take advantage of Merit’s many clinical resources. Product and procedure visual guides, disease management sheets, and prep and administration instructions are right at your fingertips.
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Physician Support

To make your life easier, Merit provides updated coding and reimbursement information. A CMS Physician Fee Schedule look-up tool provides information for more than 10,000 physician services.
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Data & Studies

Browse our list of key therapy studies that include quick links to abstracts and useful data summaries.
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Merit Medical is committed to helping you care for your patients by offering the most up-to-date information available on interventional spine treatments. Visit the Merit Spine Resource Center today and explore the many tools you can use to enhance your practice.
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Merit Medical’s Portfolio of VCF Solutions Continues to Grow: DiamondTOUCH™ Syringe and StabiliT® Introducer

This week Merit Medical announced the launch of two products that enhance their complete portfolio of vertebral compression fracture (VCF) solutions: the DiamondTOUCH™ Syringe and the StabiliT® Introducer. With the addition of these innovative products, Merit expands upon its diverse spine portfolio, further establishing its commitment to minimally invasive vertebral augmentation (balloon kyphoplasty) and vertebroplasty treatments.

NEW DiamondTOUCH Syringe – simplified bone cement delivery and balloon inflation

The DiamondTOUCH Syringe is a cutting-edge dual indication 30 mL syringe that offers both simplified bone cement delivery as well as inflation and deflation of interventional devices up to 35 ATM/500 psi. A bright LCD screen with oversized time and pressure digits provides exceptional visibility and accuracy.

From precise cement delivery to balloon inflation, the enhanced design allows for the convenience and control of one-handed precise preparation paired with quick and easy release capabilities. Moreover, the DiamondTOUCH offers a 36-inch delivery line, allowing clinicians to operate the syringe away from direct radiation.

The DiamondTOUCH Syringe is compatible with Merit’s portfolio of vertebral compression fracture products including StabiliT cement delivery and Osseoflex® balloon inflation.

NEW StabiliT Introducer – now with optimized radiolucency

The new StabiliT Introducer offers easy and safe percutaneous access to bone and is fully compatible with current and future product lines, including StabiliT, STAR™, and Osseoflex. It retains established introducer lengths (10 cm and 12 cm) and tip configurations (trocar and bevel). To enhance clarity and ease of use, tip configuration and directionality are now printed directly on the handle. The new handle design optimizes radiolucency by minimizing obstruction.

The StabiliT Introducer offers a number of new features including an ergonomic handle for increased comfort and interoperative device manipulation, depth markers on the cannula to assist with intraoperative positioning, and a snap locking mechanism engineered to be more defined and stable.

Discover for yourself the new DiamondTOUCH Syringe and improved StabiliT Introducer, and explore all the ways Merit can support your spine procedures.

Recap of SIR 2019

Announcing New Product Innovations and Education Presentations at SIR 2019 – Booth 349

As the pioneers of minimally invasive treatment, you are innovators.1 And Merit Medical is pleased to be your industry partner in innovative healthcare. This year at SIR 2019, we will introduce several new innovative products and technologies in the areas of venous therapyinterventional spineembolicsbiopsydrainage, and radial access. We are also pleased to provide several in-booth education presentations and hands-on opportunities to further your learning experience at SIR.

Innovation Education Series at the Merit Medical Booth

The Evolution of Radial Access – The Science and Practice of Distal Transradial

  • Date: Sunday, March 24, 2019
  • Time: 12:00 – 1:00 PM  *Meet and Be Educated: Lunch provided; first come, first served.
Darren Klass, MD, PhD, MRCS, FRCR, FRCPC, Interventional Radiologist, Vancouver General Hospital, Vancouver, BC
Ferdinand Kiemeneij, MD, PhD, Interventional Cardiologist, “Father of Transradial Intervention,” Tergooi, The Netherlands

Steerability in Single Access Approach for Vertebral Augmentation

  • Date: Monday, March 25, 2019
  • Time: 10:00 – 10:30 AM
Bart DolmatchBart Dolmatch, MD, Palo Alto Medical Foundation, Palo Alto, CA

How Low Can You Go? A Paradigm Change in the Treatment of Venous Insufficiency

  • Date: Monday, March 25, 2019
  • Time: 12:00 – 1:00 PM  *Meet and Be Educated: Lunch provided; first come, first served.
Michael TalMichael Tal, MD, MBA, Tel Aviv, Israel

Advanced Localization Techniques; Breast Cancer – From Biopsy to Lymph Nodes

  • Date: Tuesday, March 26, 2019
  • Time: 10:00 – 10:30 AM
Tanya W. Moseley, MD, University of Texas MD Anderson Cancer Center, Houston, TX

Targeted RF Ablative Therapy in Metastatic Spine Disease: Steerability and Clinical Evidence

  • Tuesday, March 26, 2019
  • Time: 12:00 – 1:00 PM  *Meet and Be Educated: Lunch provided; first come, first served.
Jack W. Jennings, MD, PhD, Washington University, St. Louis, MO

* The content of these sessions is not part of the SIR 2019 Annual Scientific Meeting as approved by the Annual Scientific Meeting Committee. Merit Medical is hosting this lunch in accordance with the AdvaMed Code of Ethics.

New Product Innovations and Hands-on Learning

Venous Therapy:

Interventional Spine:

Embolics:

  • New EmboCube™ Embolization Gelatin, available in two sizes (2.5 mm and 5.0 mm diameters), pre-loaded into syringes
  • Hands-on Opportunity: UFE and PAE kiosk, for clinical resources and patient-facing tools
  • Hands-on Opportunity: PAE-simulator training

Biopsy and Localization:

  • New and Improved CorVocet™ Biopsy System, designed to cut a full core of tissue and provide large specimens
  • Merit Medical recently acquired the SAVI SCOUT®, for wire-free radar localization of target tissue during breast cancer care
  • Hands-on Opportunity: Experience the SAVI SCOUT

Drainage:

Radial Access:


REFERENCES
  1. Society of Interventional Radiology. (n.d.). Nonsurgical interventional radiology procedures offer less risk, less pain and less recovery time compared to open surgery. Retrieved from https://www.mirmss.org/uploads/2/0/7/9/20795846/about_interventional_radiology.pdf
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