IRVINE, Calif.--(BUSINESS WIRE)--CardiAQ Valve Technologies (CardiAQ), today announced that it has received a 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. 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. CardiAQ also announced that Beth Israel Deaconess Imaging Core Laboratory will serve as the core lab for its 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.
“The FDA’s new draft guidance, ‘Investigational Device Exemptions (IDE’s) for Early Feasibility Medical Device Clinical Studies, including Certain First in Human (FIH) Studies’, is a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, VP Regulatory Affairs, Quality Assurance & 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 US patients much earlier.”
“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.”
“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.”
“Obtaining an early feasibility IDE approval in the US represents a pivotal milestone in establishing Transcatheter Mitral Valve Implantation as the next-generation, less-invasive therapy for structural heart therapy because early participation of US investigative centers will fast-forward clinical understanding and adoption of CardiAQ’s technology,” added CEO Rob Michiels.
Privately held CardiAQ, headquartered in Irvine, Calif., has developed a proprietary Transcatheter Mitral Valve (TMV) Implant that 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, 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 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.
Caution: The CardiAQ™ Valve Technologies Systems for Transcatheter Mitral Valve Implantation are in the early phases of clinical development and will be undergoing clinical trials in the USA and overseas until further notice. The CardiAQ TMVI technology is limited by Federal law to investigaional use only and is NOT available for sale.