www.fdanews.com/articles/208155-%C5%8Dn%C5%8Dcor-receives-fda-clearance-for-its-endovascular-retrieval-technology
ŌNŌCOR Receives FDA Clearance for Its Endovascular Retrieval Technology
June 9, 2022
ŌNŌCOR has received 510(k) clearance from the FDA for its ŌNŌ retrieval system for use in catheter-based therapies.
The ŌNŌ system, which is designed to compress and remove suboptimal or embolized devices from the vascular system, is compatible with commercially available vascular sheaths and endovascular snares, according to the Philadelphia, Pa.-based company.
Catheter-based procedures are considered safer alternatives to open-heart surgical procedures, but problems such as device misplacement, embolization or improperly functioning implants can require a rescue procedure to remove the device.