CardiAQ Valve Technologies today said it won a nod from the FDA for an early feasibility trial of its 2nd-generation transcatheter mitral valve implant.
The 20-patient trial will enroll 10 subjects to be treated transfemorally and another 10 treated via the transapical approach, Irvine, Calif.-based CardiAQ Valve said. Boston’s Beth Israel Deaconess Medical Center will serve as the core lab for the study, the company said.
"Obtaining an early feasibility IDE approval in the U.S. 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 U.S. investigative centers will fast-forward clinical understanding and adoption of CardiAQ’s technology," CEO Rob Michiels said in prepared remarks.
Co-founder, president & COO Brent Ratz said CardiAQ is the only company with successful transfemoral and transapical TMVIs under its belt.
“The approval of this study is a major step forward for the clinical development of CardiAQ’s groundbreaking TMVI platform and, for the 1st time ever, will give U.S. heart teams the choice of a mitral valve that can be delivered either transfemorally or transapically," Ratz said.
"CardiAQ’s 2nd-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," co-founder & CMO Dr. Arshad Quadri added. "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."