REGULATORY NEWS

St. Jude nets FDA, CE Mark clearance for new vascular closure device

Written by Editorial Staff   
October 16, 2008
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WASHINGTON—St. Jude Medical has received FDA and European CE Mark approval of the Angio-Seal Evolution vascular closure device. The approval and global launch were announced this week at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

The Angio-Seal Evolution device is designed to enable physicians to seal femoral artery punctures made during minimally invasive catheter-based procedures, according to the St. Paul, Minn.-based company.

St. Jude said its Angio-Seal Evolution platform features a new single-handed delivery system that reduces the variability that can occur as physicians deploy and secure the Angio-Seal closure system. The new device’s collagen compaction system ensures compaction of the collagen against the exterior wall of the vessel.