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Merit Medical gets FDA nod for Siege™ vascular plug

Merit Medical Systems, Inc. announced US Food and Drug Administration (FDA) 510(k) clearance for its Siege Vascular Plug. Merit also announced the launch of its Bearing nsPVA Express Prefilled Syringe in the United States and Australia.

The latest additions to Merit’s Embolics portfolio, Siege Vascular Plug and Bearing nsPVA Express, complement a comprehensive offering of microsphere, particle, and gelatin foam products supported by a range of microcatheters, guide wires, and other enabling devices.

Embolization is a minimally invasive procedure where physicians implant devices or materials to occlude blood vessels or abnormal vascular channels. It may be used to stop bleeding or to block the flow of blood to a tumor or abnormal area of tissue. Embolization has made remarkable advances in recent years, becoming a widely adopted treatment option.

The Siege Vascular Plug has a highly deliverable, recapturable design that enables precise placement. The nitinol self-expanding plug achieves vessel occlusion within 1.3 minutes. Available in three sizes, Siege treats peripheral arteries 1.5 mm to 6.0 mm in diameter. All sizes of the Siege Vascular Plug are delivered with a microcatheter.

“The Siege Vascular Plug will be a valuable addition to my clinical practice. A plug with rapid occlusion, precise placement, and microcatheter compatibility is important to me,” said Gary Siskin, MD, Professor and Chairman of the Radiology Department at Albany Medical Center in Albany, NY, and paid consultant of Merit.

The newly launched Bearing nsPVA Express is a 20-mL, vacuum-sealed syringe prefilled with Merit-manufactured Bearing nsPVA® Embolization Particles. Bearing nsPVA Embolization Particles are small, irregularly shaped, biocompatible, hydrophilic, and nonresorbable particles available in multiple sizes (45-1180 µm). The preloaded syringe offers convenience and ease of use that can save clinicians’ time and minimize product waste. In hands-on testing, 100% of clinicians found the Bearing nsPVA Express to be easily incorporated into a procedure, and 75% said it was easier to use than the vial product.

“Bearing nsPVA Express streamlines embolization procedures. It eliminates a number of steps involved in using PVA in a vial,” said Jafar Golzarian, MD, Interventional Radiologist and Founder at Northstar Vascular and Interventional in Golden Valley, MN. “Unlike vial products, it’s ready to use, enabling interventional radiologists to focus on the procedure.”

As part of its commitment to innovation, education, and research in embolotherapy, Merit will participate in the 18th Annual Global Embolization Oncology Symposium Technologies (GEST) Meeting, to be held May 16-19, 2024, in New York City, NY. In addition to introducing the Siege Vascular Plug and Bearing nsPVA Express, Merit will be exhibiting other embolic product solutions, including Embosphere® Microspheres, EmboCube™ Embolization Gelatin, and Torpedo™ Gelatin Foam. Merit will also feature the SwiftNINJA® Steerable Microcatheter and the longer-length Merit Maestro® Microcatheter; both delivery systems are ideal for radial procedures.

Physicians can try these products through hands-on workshops held at the Merit booth. GEST attendees will also have access to Merit’s simulator for added prostatic artery embolization and uterine fibroid embolization experience involving Embosphere Microspheres and other Merit devices.

“Merit is a leader in embolotherapy,” said Fred P. Lampropoulos, Merit Chairman and Chief Executive Officer. “Through continued investment in new product solutions, we have developed a strong record of delivering meaningful innovation, new indications, and portfolio extensions designed to meet the needs of our healthcare partners. We look forward to demonstrating this excellence at GEST, showcasing the ways we help physicians deliver a better patient experience.”
MB Bureau

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