Merit Medical Systems, a global leader of healthcare technology, has announced US Food and Drug Administration (FDA) 510(k) clearance for its Siege vascular plug. Merit also announced the launch of its Bearing non-spherical polyvinyl alcohol (nsPVA) Express prefilled syringe in the USA and Australia.
The latest additions to Merit’s embolics portfolio, Siege vascularplug and Bearing nsPVA Express, complement a comprehensive offering of microsphere, particle, and gelatine 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 tumour or abnormal area of tissue. Embolization has made remarkable advances in recent years, becoming a widely adopted treatment option, the recent Merit press release states.
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 1.5mm to 6mm 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 (Albany Medical Center, Albany, USA), paid consultant of Merit.
The newly launched Bearing nsPVA Express is a 20mL, vacuum-sealed syringe prefilled with Merit-manufactured Bearing nsPVA embolization particles. Bearing nsPVA embolization particles are small, irregularly shaped, biocompatible, hydrophilic, and non-resorbable particles available in multiple sizes (45-1180µm). The preloaded syringe offers convenience and ease of use that can save clinicians’ time and minimise 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, founder of Northstar Vascular and Interventional in Golden Valley, USA. “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) annual meeting (16–19 May, 2024, New York City, USA). 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 gelatine, and Torpedo gelatine 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.”
