Endovascular Devices Articles & Analysis
6 news found
Thoraflex Hybrid is the first of its kind device used in Frozen Elephant Trunk (FET) repair in the United States and was granted Breakthrough Device Designation by the FDA in 2021. ...
Saluda Medical Pty Limited (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced neural activation and sensing technologies designed to treat debilitating neurological disorders, today announced the appointment of Robert (Bob) Palmisano to its Board of Directors. ...
Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. ...
Centerline Biomedical, Inc. was one of eleven companies selected to present during the Disruptive Technology for Endovascular Therapy sessions during this year’s Vascular InterVentional Advances (VIVA) meeting. Company CTO Vikash Goel presented the Cleveland Clinic spinoff’s Intra-Operative Positioning System (IOPS) technology to an audience of vascular surgeons, ...
(“SSI”) announced today the signing of a development agreement with a confidential strategic partner whose long standing market leadership position in endovascular device therapies makes it an ideal partner to continue development of novel microwave ablation technologies. As part of this agreement both parties will explore technological synergies and ...
The purpose of this guide is to provide a procedure for determining the appropriate attributes to evaluate in a shelf-life study for an endovascular device. 1. Scope 1.1 This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for ...