FDA Approves IDE for U.S. Feasibility Study of CardiAQ’s TMVI Technology

CardiAQ Valve Technologies of Irvine, Calif., received U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) approval to conduct an early feasibility study using the CardiAQ Second-Generation Transfemoral (TF) and Transapical (TA) Transcatheter Mitral Valve Implantation (TMVI) Systems.

“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 chief operating officer. “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 U.S. heart teams the choice of a mitral valve that can be delivered either transfemorally or transapically.”

The study will enroll up to 20 patients (10 TF and 10 TA) and multi-disciplinary physician teams at select U.S. sites will start enrollment once hospital approvals and agreements are in place. CardiAQ also recently announced that Beth Israel Deaconess Imaging Core Laboratory will serve as the core lab for its U.S. studies and studies outside he United States under the leadership of Jeffrey Popma, M.D., director, interventional cardiology, Beth Israel Deaconess Medical Center and professor of medicine, Harvard Medical School, Boston, Mass.

“The FDA’s new draft guidance, ‘Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, including Certain First in Human Studies,’ is a relatively new approach to clinical studies conducted in the early stages of development, and is designed to facilitate early clinical experience with investigational medical devices to reach patients sooner and to create innovation capabilities within the United States,” said Paul Cornelison, vice president of regulatory affairs, quality assurance and clinical affairs at CardiAQ. “Through its application and close collaboration with the FDA, we are delighted to be able to bring our self-conforming, self-anchoring implant technology to U.S. patients much earlier.”

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,” according to Arshad Quadri, M.D., cardiac surgeon, founder, and chief medical officer. “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 U.S.”

CEO Rob Michiels called obtaining an early feasibility IDE approval in the United States “a pivotal milestone” in establishing transcatheter mitral valve implantation as “the next-generation, less-invasive therapy for structural heart therapy because early participation of U.S. investigative centers will fast-forward clinical understanding and adoption of CardiAQ’s technology.”

Privately held CardiAQ has developed a proprietary TMV implant that can be delivered through multiple delivery systems, including transfemoral and transapical.
The firm’s unique anchoring mechanism uses the patient’s native mitral valve anatomy, through which physicians can implant a new mitral valve within a beating heart without circulatory support, thus avoiding open-heart surgery, according to company officials. CardiAQ TMVI procedures are designed to be performed in a cardiac catheterization laboratory or hybrid operating room. The procedure is expected to result in less trauma to the patient and cost-savings to the healthcare system.