CardiAQ Reports First-in-Human Transcatheter Mitral Valve Implantation

Nearly 50 percent of patients with severe mitral heart regurgitation are denied open-heart surgery because of risk, but transcatheter mitral valve implantation


June 15, 2012

June 15, 2012 — CardiAQ Valve Technologies (CardiAQ), which has developed the world’s first self-conforming and self-anchoring technology for nonsurgical transcatheter mitral valve implantation (TMVI), announced that the company has achieved a cardiovascular medicine milestone: a bioprosthetic mitral heart valve was successfully implanted as a compassionate treatment into an 86-year-old male suffering from severe mitral regurgitation (MR 4+). The TMVI procedure was performed June 12 at The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark, by interventional cardiologists Lars Søndergaard, M.D., and Olaf Franzen, M.D., cardiovascular surgeon Susanne Holme, M.D., anesthesiologist Peter Bo Hansen, M.D., and echocardiographer Nikolaj Ihlemann, M.D.

“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, CEO of CardiAQ Valve Technologies. “CardiAQ is currently the only transcatheter-transvessel implantation approach to treating MR. While several companies have been trying to perfect a percutaneous approach to repair the mitral valve, we believe that such technologies will have a very difficult time demonstrating sufficient efficacy in treating such a heterogeneous disease,” added Michiels. “CardiAQ’s nonsurgical valve implantation approach is designed to become a disruptive technology with a much broader application.”

“CardiAQ has focused on replacement or implantation — not repair — for three reasons. Replacement of the diseased mitral valve offers: 1. the best chance of eliminating regurgitation; 2. the widest applicability across patient and disease variations; and 3. can be made into a simple, fast, straightforward interventional — i.e., nonsurgical — procedure,” said Brent Ratz, co-founder and COO.

“As cardiac surgeons, we are taught that residual mitral regurgitation will only lead to more mitral regurgitation and progressive symptoms. That is why we have focused our efforts on developing a replacement technology with the potential to eliminate clinically significant MR, not just reduce it,” said Arshad Quadri, M.D., chairman, founder/inventor and CMO of CardiAQ. “Moreover, many of these inoperable patients suffer from functional MR, which is actually a result of ventricular dilatation. CardiAQ’s chordal-sparing approach, combined with its unique anchoring system, provides what can best be described as a ‘face-lift for the heart’ that may also help promote positive remodeling of the ventricle.”

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