Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

pharmiweb.com today archive

2174 PWToday Stories

Caisson Interventional Completes First in Human Implants of Its Transvascular Mitral Valve Replacement

19 Sep 16

Caisson Interventional, LLC announces the first successful human implants of its fully percutaneous, transvascular mitral valve implant designed as a functional replacement in a diseased, damaged, or malfunctioning mitral valve.

Mathew R. Williams, M.D. and his team from the Heart Valve Center at NYU Langone successfully implanted three patients with the Caisson Transcatheter Mitral Valve System.  These are the first patients enrolled in the PRELUDE Study ( P ercutaneous Mitral Valve  R eplacement  E va L uation  U tilizing I D E  E arly Feasibility Study).  The study is designed to provide initial data on the safety and performance of the Caisson TMVR System.  The U.S. Food and Drug Administration (FDA) approved the Investigational Device Exemption (IDE) for the PRELUDE study under the Early Feasibility Study program for up to 20 patients in 5 centers.

The Company also reports one patient was successfully implanted in July under the direction of Eric Cohen, M.D. and Gideon Cohen, M.D. at the Schulich Heart Centre at Sunnybrook Health Sciences Centre (Toronto) under the Health Canada Special Access Programme.

The physicians involved stated the patients responded very well to the implant with excellent valve function.  They also commented the delivery system performed as designed and facilitated proper placement of the implant with precise control at each stepof the procedure.

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.