News | May 12, 2015

FDA Grants IDE Approval for CardiAQ’s Transcatheter Mitral Valve Feasibility Study

Novel treatment offers transfemoral and transapical implantation options

CardiAQ, TMVI, FDA, IDE, feasibility study, mitral valve, Beth Israel Deaconess

May 12, 2015 — CardiAQ Valve Technologies announced U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for a feasibility study of its second generation transfemoral (TF) and transapical (TA) transcatheter mitral valve implantation systems. The study will enroll up to 20 patients (10 TF and 10 TA) and multidisciplinary physician teams at select U.S. sites will start enrollment once hospital approvals and agreements are in place. 

CardiAQ also announced that Beth Israel Deaconess Imaging Core Laboratory will serve as the core lab for its United States and outside the United States (OUS) studies. Jeffrey Popma, M.D., director, interventional cardiology, Beth Israel Deaconess Medical Center and professor of medicine, Harvard Medical School, will lead the trial.

The company’s proprietary transcatheter mitral valve implant can be delivered through multiple delivery systems, including both transfemoral and transapical. The system features a unique anchoring mechanism that engages and utilizes the patient’s native mitral valve anatomy, allowing physicians to accurately and securely implant a new mitral valve within a beating heart without circulatory support, thus avoiding open-heart surgery.

The CardiAQ TMVI procedures are designed to be performed in a cardiac catheterization laboratory or hybrid operating room. Ultimately, the procedure will result in less trauma to the patient and substantial potential cost-savings to the healthcare system.

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