First-in-Human Transfemoral-Transseptal Procedure Conducted With CardiAQ's Second-Generation TMVI Device

June 23, 2015—CardiAQ Valve Technologies announced the first-in-human percutaneous transfemoral-transseptal implantation of its second-generation transcatheter bioprosthetic mitral heart valve, which is based upon the company’s self-conforming and self-anchoring technology for transcatheter mitral valve implantation (TMVI).

According to the company, the second-generation bioprosthetic mitral heart valve was successfully implanted as a compassionate treatment into a 72-year-old man who had severe mitral regurgitation (MR 4+) with multiple comorbidities and was ineligible for alternate treatment modalities. The device’s anchoring mechanism engages and utilizes the patient’s native mitral valve anatomy, enabling physicians to accurately and securely implant a new mitral valve via the transcatheter intervention.

An experienced Heart Team led by Director of Cardiology, Francesco Romeo, MD, and interventional cardiologist Gian Paolo Ussia, MD, performed the TMVI procedure at the Tor Vergata Hospital in Rome, Italy. The procedure team included the device’s inventor, Arshad Quadri, MD, a cardiovascular surgeon with Saint Francis Hospital in Hartford, Connecticut.

In the company’s press release, Dr. Ussia commented, “We have now performed three CardiAQ TMVI cases (two transapical and one transseptal) 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.”

Dr. Quadri added, “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 catheterization lab is truly remarkable.”

The company advised that additional transseptal feasibility cases will be conducted over the next few months, and it anticipates starting the European CE Mark clinical trial for its transseptal technology by the end of summer. The company is also about to initiate the European CE Mark trial for its transapical system, which has completed nine feasibility cases.

The company cautioned that the CardiAQ valve technologies systems for TMVI are in the early phases of clinical development and will be undergoing clinical trials in the United States and overseas until further notice. The CardiAQ TMVI technology is limited by Federal law to investigational use only and is not available for sale.