CardiAQ Valve Technologies has obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to carry out an early feasibility study using the CardiAQ Second-Generation Transfemoral (TF) and Transapical (TA) Transcatheter Mitral Valve Implantation (TMVI) Systems.
Under the study, the company will enroll up to 20 patients, including 10 each with TF and TA systems.
After the completion of hospital approvals and agreements, the multi-disciplinary physician teams at select US sites will commence the enrollment of patients.
CardiAQ Valve Technologies co-founder, president and COO Brent Ratz said: "CardiAQ remains the only company on this new medical frontier to have successfully accomplished both transfemoral and transapical human mitral valve implantations.
"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."
CardiAQ noted that Beth Israel Deaconess Imaging Core Laboratory will serve as the core lab for its US and OUS studies under the leadership of Harvard Medical School medicine professor and Beth Israel Deaconess Medical Center interventional cardiology director Jeffrey Popma.
The approval will allow the US clinical investigators to evaluate the feasibility and safety of the two CardiAQ Systems in preparation for a future pivotal study.
According to the company, TMVI is expected to be a novel definitive treatment for patients suffering from severe, symptomatic mitral regurgitation and who are high-risk candidates for open heart surgery.