FDA OKs US Early Feasibility Study of CardiAQ™ Transcatheter Mitral Valve

CardiAQ Valve Technologies has received a U.S. FDA Investigational Device Exemption (IDE) approval to conduct an early feasibility study using its Second-Generation Transfemoral (TF) and Transapical (TA) Transcatheter Mitral Valve Implantation (TMVI) Systems.

Background

Transcatheter Aortic Valve Replacement (TAVR) is becoming an established treatment option, the next nut to crack being transcatheter mitral valve repair (TMVR) as evidenced at last year’s Transcatheter Cardiovascular Therapeutics (TCT), sessions on this topic being packed to capacity.

All the usual suspects are developing their TMVR programs, one such being CardiAQ Valve Technologies. CardiAQ’s proprietary implant can be delivered through multiple delivery systems, including both Transfemoral and Transapical. Through its unique anchoring mechanism that engages and utilizes the patient’s native mitral valve anatomy, the company says physicians will be able to accurately and securely implant a new mitral valve within a beating heart without circulatory support, thus avoiding open-heart surgery.

The study will enroll up to 20 patients (10 TF and 10 TA) and multi-disciplinary physician teams at select US sites will start enrollment once hospital approvals and agreements are in place. Beth Israel Deaconess Imaging Core Laboratory will serve as the core lab for CardiAQ’s US and OUS studies under the leadership of Jeffrey Popma, MD, Director, Interventional Cardiology, Beth Israel Deaconess Medical Center and Professor of Medicine, Harvard Medical School.

Physician comments

“CardiAQ’s second generation TMVI products are built upon the company’s proprietary method for anchoring the implant through leaflet engagement, chordal preservation, and annular attachment, while offering greater durability, improved flow properties, and a novel feature for the prevention of paravalvular leaks,” said Arshad Quadri, MD, Cardiac Surgeon, Founder, and CMO. “As a practicing physician who treats patients with mitral regurgitation, I am personally excited that we are now in a position to bring this technology to high-risk patients in the US.”

Company comments

“CardiAQ remains the only company on this new medical frontier to have successfully accomplished both transfemoral and transapical human mitral valve implantations,” said Brent Ratz, Co-Founder, President and COO. “The approval of this study is a major step forward for the clinical development of CardiAQ’s groundbreaking TMVI platform and, for the first time ever, will give US heart teams the choice of a mitral valve that can be delivered either transfemorally or transapically.”

 Source: CardiAQ Valve Technologies

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