Embolx said today it won CE Mark approval in the European Union for its Sniper Balloon occlusion microcatheters designed for pressure-directed arterial embolization therapy.
The Sunnyvale, Calif.-based company said that the newly cleared Sniper Balloon catheter features improvements 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.
“CE Marking is an important milestone for Embolx, as we can now offer the most advanced transarterial embolization delivery system to physicians and patients in Europe. For patients, the system’s ability to redirect blood flow away from surrounding organs and eliminate reflux may result in better outcomes and fewer side effects,” prez & CEO Michael Allen said in a prepared statement.
“We’ve used Sniper in approximately 50 prostate arterial embolizations so far this year, and we’ve seen improved outcomes with fewer adverse events when compared to conventional microcatheter embolization. Because Sniper prevents reflux and redirects blood and embolic flow, coils are not needed in these procedures. In addition, the new 150 cm length allows us to perform prostate arterial embolization using a transradial approach,” Dr. Tiago Bilhim of Lisbon, Portugal’s Hospital Saint Louis said in a press release.
In June, Embolx said that it won FDA 510(k) clearance for its next-gen Sniper balloon caths.