CardiAQ Valve Technologies has received FDA investigational device exemption approval for a US early feasibility study of its second-generation transfemoral and transapical transcatheter mitral valve implantation system. With this study approval, a company press release reports, US clinical investigators will now be able to commence assessing the feasibility and safety of the two CardiAQ Systems in preparation for a future pivotal study.
The study will enrol up to 20 patients (10 transfemoral and 10 transapical) and multi-disciplinary physician teams at select US sites will start enrolment once hospital approvals and agreements are in place. CardiAQ has also announced that Beth Israel Deaconess Imaging Core Laboratory will serve as the core lab for its US and outside of the US studies under the leadership of Jeffrey Popma (director, Interventional Cardiology, Beth Israel Deaconess Medical Center and professor of Medicine, Harvard Medical School, USA).
Paul Cornelison, VP Regulatory Affairs, Quality Assurance & Clinical Affairs at CardiAQ, says: “The FDA’s new draft guidance, ‘investigational device exemptions for early feasibility medical device clinical studies, including certain first in human studies’, is a relatively new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 USA. 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’s second generation transcatheter mitral valve implantation 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 (cardiac surgeon, founder, and chief medical officer of the company). “As a practising 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 USA.”