First-in-Human Nonsurgical Percutaneous Bioprosthetic Mitral Heart Valve Implant

In short

CardiAQ™ Valve Technologies , which has developed the world’s first self-conforming and self-anchoring technology for nonsurgical Transcatheter Mitral Valve Implantation (TMVI), has announced that it’s bioprosthetic mitral heart valve has been successfully implanted as a compassionate treatment into an 86-year-old male suffering from severe mitral regurgitation (MR 4+).

Background

Californian company CardiAQ Valve Technologies, has developed a proprietary system for Transcatheter Mitral Valve Implantation (TMVI). In a news release published on the Healthcare Sales and Marketing Network, the company claims that through the combination of a unique anchoring mechanism and a novel delivery catheter, physicians will be able to accurately and securely implant a new mitral valve within a beating heart, thus avoiding open-heart surgery.

The CardiAQ procedure is designed to be performed in a cardiac catheterization laboratory or hybrid operating room and could ultimately be performed line an angioplasty or stent insertion, resulting in less trauma to the patient and substantial potential cost-savings to the healthcare system.

The breakthrough TMVI procedure was performed on June 12, 2012, 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.

Company comments

“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.”

Source:  CardiAQ Valve Technologies, Healthcare Sales and Marketing Network