Caisson Interventional has announced the first successful human implants of its fully percutaneous, transvascular mitral valve implant, which is designed as a functional replacement in a diseased, damaged, or malfunctioning mitral valve. Mathew R Williams (Heart Valve Center, NYU Langone, New York, USA) and his team from the successfully implanted three patients with the Caisson transcatheter mitral valve system.
According to a press release, these are the first patients enrolled in the PRELUDE Study (Percutaneous mitral valve replacement evaluation utilising the investigational device exemption early feasibility study). The study is designed to provide initial data on the safety and performance of the Caisson transcatheter mitral valve implantation (TMVI) system. The FDA approved the IDE for the PRELUDE study under the early feasibility study programme for up to 20 patients in five centres.
The Caisson implant consists of two components—an anchor constructed of a nitinol frame and a pericardial tissue valve attached to a nitinol frame. The implant is fully repositionable and retrievable and only released after the function of the implant is fully assessed. The entire procedure is completed through a single percutaneous femoral venous access using a trans-septal approach to the native mitral valve.
The physicians involved with TMVI procedures 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 step of the procedure. Williams said: “NYU Langone is a recognised world leader in cardiac care and we are dedicated to bringing the most advanced minimally-invasive technologies to our patients. We are proud to be the first medical centre in the world to successfully implant three high risk patients with Caisson’s cutting-edge new technology to treat their severe symptomatic mitral regurgitation. Thanks to NYU Langone’s focus on innovation in the field, and the FDA’s dedication to the early feasibility study programme, we have the opportunity to be involved with this first-in-class technology at the earliest stage of clinical evaluation.”
The press release notes that one patient was successfully implanted in July under the direction of Eric Cohen and Gideon Cohen (Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, Canada) under the Health Canada special access programme.