Medical devices maker Embolx has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its next generation Sniper balloon occlusion microcatheter for pressure-directed arterial embolization therapy.
The next-generation family of Sniper devices will deliver pressure-directed therapy for tumors, enlarged prostate and fibroids.
Sniper balloon occlusion microcatheter will help physicians to improve access and navigate through small complex vascular structures.
The next-generation Sniper microcatheter is available in three lengths, including 110cm, 130cm and 150 cm. The different lengths will enable interventional radiologist physicians to access either femoral or radial arterial sites.
The advanced designs of Sniper’s balloon and atraumatic tip allow to occlude larger vessels and track inside vessels.
Embolx president and CEO Michael Allen said: “Our next generation devices incorporate experience from more than 1,000 Sniper balloon occlusion microcatheters used to date.
“Now, interventional radiologists can do everything they would do with standard microcatheters, but with the added benefits of balloon occlusion. This is a big step forward and provides physicians with the most advanced transarterial delivery system for tumor and prostate treatment.”
The new microcatheter varies blood flow‐dynamics by controlling pressure to increase therapeutic agent delivery into target areas.
Embolx’s microcatheter is currently used for the treatment of cancerous tumors in the liver and other organs, enlarged prostate and uterine fibroids.
According to the company, the therapy enables to deliver drugs and embolic agents to only targeted treatment areas, while protecting surrounding healthy tissues.
Mount Sinai’s Icahn School of Medicine of radiology and surgery associate professor and interventional radiologist Dr Aaron Fischman said: “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.”
Based in Silicon Valley, Embolx is an emerging commercial-stage medical device company engaged in the development of microcatheters for arterial embolization procedures.