CardiAQ reports first-in-human percutaneous implantation with its second generation transcatheter bioprosthetic mitral heart valve


Nearly 50% of patients suffering from a diseased mitral heart valve with severe, symptomatic regurgitation are currently denied open-heart surgery because it is considered too risky. In the future, percutaneous transcatheter mitral valve implantation (TMVI) may offer new hope for these patients.

CardiAQ’s second-generation bioprosthetic mitral heart valve was successfully implanted as a compassionate treatment into a 72-year-old male suffering from severe mitral regurgitation (MR 4+) with multiple co-morbidities and ineligible for alternate treatment modalities. The procedure was performed at the Tor Vergata Hospital in Rome, Italy, by a heart team led by director of cardiology, Francesco Romeo, and interventional cardiologist Gian Paolo Ussia, also including cardiac surgeon Giovanni Ruvolo, anesthesiologist Pasquale De Vico and echocardiographer Valeria Cammalleri. Interventional cardiologist Lars Sondergaard (Rigshospitalet, Copenhagen, Denmark) and cardiovascular surgeon and inventor of the CardiAQ TMVI technology Arshad Quadri (St Francis Hospital, Hartford, USA) also participated. 

“Our TMVI system is designed to make nonsurgical mitral heart valve replacement a future alternative to open-heart surgical replacement and repair,” said Rob Michiels, chief executive officer of CardiAQ. “CardiAQ currently offers the only transvessel implantation approach to treating mitral regurgitation. While several organisations have focused on a transapical approach to replace the mitral valve, we are the only company to have realised transfemoral-transseptal human implants,” he added.

“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 nine feasibility cases,” said Brent Ratz, co-founder and chief operating officer. “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.”

“These untreatable patients are the reason I founded this company, and these are the patients we need to be able to help,” added Quadri. “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.”

“We have now performed three CardiAQ TMVI cases (two transapical and one transseptal) at Tor Vergata with excellent results, reducing the severe mitral regurgitation to trace and with no mitral or outflow tract gradients,” said Gian Paolo Ussia, primary investigator at the Rome Hospital. “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.”