FDA Clears Embolx's Next-Generation Sniper Balloon Occlusion Microcatheter
June 28, 2018—Embolx, Inc. announced that the company has received 510(k) clearance from the US Food and Drug Administration (FDA) for its next-generation family of Sniper balloon occlusion microcatheters, which provide pressure-directed arterial embolization therapy.
According to the company, Embolx’s next-generation family of Sniper devices has enhanced performance features to improve access and allow easy navigation through small, complex vascular structures. The microcatheter is now available in three lengths (110, 130, and 150 cm) to enable access through either femoral or radial arterial sites. Advancements in the Sniper’s balloon and atraumatic tip designs allow larger vessels to be occluded and enhance the ability for Sniper to track inside vessels.
The Sniper microcatheter, which alters blood flow dynamics by controlling pressure to increase therapeutic agent delivery into target areas, is currently used for the treatment of cancerous tumors in the liver and other organs, benign prostatic hyperplasia, and uterine fibroids. This therapy allows the delivery of drugs and embolic agents to only targeted treatment areas while protecting surrounding healthy tissues.
In Embolx’s press release, Aaron M. Fischman, MD, commented, "The great thing about Sniper's enhanced design and longer lengths is that it allows me to perform procedures using a transradial approach with the benefits of pressure-directed embolization. The ability to reverse blood flow using Sniper's balloon helps me to not have to worry about nontarget embolization. I can perform the procedure the way I want because of Sniper's wide range of compatibility with different guidewires, guide catheters, coils and therapeutic agents." Dr. Fischman, an interventional radiologist, is Associate Professor of Radiology and Surgery at the Icahn School of Medicine at Mount Sinai in New York, New York.