Embolx said today that it won FDA 510(k) clearance for its next-gen Sniper balloon occlusion microcatheters designed for pressure-directed arterial embolization therapy.
The Sunnyvale, Calif.-based company said that improvements to its next-gen Sniper microcath are intended to enhance access and navigation through small complex vascular structures. The catheter is available in 110 cm, 130 cm and 150 cm lengths to allow for access in either femoral or radial artery sites.
“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 non-target embolization. I can perform the procedure the way I want because of Sniper’s wide range compatibility with different guidewires, guide catheters, coils and therapeutic agents,” Dr. Aaron Fischman of the Icahn School of Medicine at Mount Sinai said in a prepared statement.
The Sniper Microcatheter is intended to alter blood flow dynamics by controlling pressure to allow for increased therapeutic agent delivery into target areas, and is currently used for treating cancerous tumors in the liver and other organs.
“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,” prez & CEO Michael Allen said in a press release.
In April, Embolx said that it landed a $2 million grant from the National Cancer Institute to fund development of its next-generation Sniper balloon occlusion microcatheter.