Feasibility Trial Approved by FDA for CardiAQ's Second-Generation TMVR System

April 10, 2015—CardiAQ Valve Technologies announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct an early feasibility study using the company’s CardiAQ second-generation transfemoral (TF) and transapical (TA) transcatheter mitral valve replacement (TMVR) systems. The CardiAQ devices feature an anchoring mechanism that engages and utilizes the patient’s native mitral valve anatomy so that physicians can accurately and securely implant a new mitral valve within a beating heart without circulatory support.

With this approval, clinical investigators in the United States will be able to commence assessing the feasibility and safety of the two CardiAQ systems to treat patients with severe, symptomatic mitral regurgitation who are high-risk candidates for open heart surgery. These studies will be conducted in preparation for a future pivotal study.

According to the company, the study will enroll up to 20 patients (10 TF and 10 TA). Multidisciplinary physician teams at select sites in the United States will start enrollment when 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 United States studies under the leadership of Jeffrey Popma, MD. Dr. Popma is Director, Interventional Cardiology at Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School in Boston, Massachusetts.