CardiAQ Valve Technologies said yesterday that it successfully implanted its 2nd generation transcatheter bioprosthetic mitral heart valve.
The procedure was performed in Tor Vergata Hospital in Rome, Italy on a 72-year-old male suffering from severe mitral regurgitation who was ineligible for alternate treatments, the Irvine, Calif.-based company said.
“These untreatable patients are the reason I founded this company, and these are the patients we need to be able to help. It has taken a tremendous amount of work to get to this point, but I have never been more excited about the future of this technology and of TMVI. The ability to do a fully percutaneous mitral valve replacement with no incisions, no bypass support, and being able to extubate the patient while still in the cath lab is truly remarkable,” co-founder Dr. Arshad Quadri said in a press release.
“We have now performed three CardiAQ TMVI cases at Tor Vergata with excellent results, reducing the severe MR to trace and with no mitral or outflow tract gradients. We are convinced that these new procedures will in the future represent a substantial treatment improvement for our patients with mitral valve disease. Our heart team is excited to be a part of these groundbreaking clinical trials,” primary investigator Dr. Gian Paolo Ussia said in a prepared statement.
A CE Mark clinical trial for clearance in the European Union is slated for the end of summer, the company said.
“Additional transseptal feasibility cases will take place over the next few months, and we anticipate starting the European CE Mark clinical trial for our transseptal technology by the end of summer. Meanwhile, we are about to initiate the European CE Mark trial for our transapical system, which has already completed 9 feasibility cases. We are confident that the CardiAQ’s TMVI system will become a disruptive technology with an application as broad as the transcatheter aortic valve technology that was pioneered a decade ago,” COO Brent Ratz said in prepared remarks.
In April, CardiAQ 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 is slated to enroll 10 subjects to be treated transfemorally and another 10 treated via the transapical approach, CardiAQ Valve said. Boston’s Beth Israel Deaconess Medical Center will serve as the core lab for the study, the company said.