CardiAQ Valve Technologies to Pursue First-in-Man Studies of Its Transcatheter Mitral Valve System

January 12, 2010—CardiAQ Valve Technologies, Inc. (CVT, Winchester, MA) announced that it has received funding that will be used to technically and clinically validate the company’s CVT technology, including initial first-in-man studies. The company’s CVT is a self-conforming and self-anchoring technology for transcatheter mitral valve implantation (TMVI) developed by company founder and interventional cardiologist, Arsha Quadri, MD. Private investors with experience in the transcatheter heart valve field will provide $6.5 million in Series A funding.

According to the company, the CVT TMVI technology is intended to treat patients with functional mitral regurgitation who are often too sick to have surgery. The company hopes to demonstrate that its valve replacement technology will facilitate a nonsurgical alternative that could be more effective than transcatheter repair and just as effective as surgical replacement. TMVI combines an anchoring mechanism and a delivery catheter to enable accurate and secure implantation of a new mitral valve within a beating heart. CVT is designed to be performed in a cardiac catheterization laboratory. By avoiding open surgery, the procedure will result in less trauma to the patient and substantial cost-savings to the health care system, the company stated.

In September, Joseph E. Bavaria, MD, presented successful results of an acute in vivo study of the CVT TMVI system at the Transcatheter Cardiovascular Therapeutics 2009 scientific meeting in Washington.

According to the company, Dr. Bavaria reported five major outcomes of the acute in vivo study of TMVI: accurate positioning of the implanted valve relative to the mitral valve annulus; secure anchoring of the implanted valve to the mitral anatomy without relying on radial force; preservation of the subvalvular apparatus; conformance of the implanted valve to the mitral annulus to prevent paravalvular leaks; and confirmation of a clear, unobstructed left ventricular outflow tract.

"Early data suggest that TMVI has the potential to offer a non-surgical solution to mitral regurgitation that will probably be more effective than percutaneous mitral valve repair and potentially as effective as surgical mitral valve replacement," commented Dr. Bavaria who is Vice Chief of cardiothoracic surgery at the Hospital of the University of Pennsylvania and serves as chairman of CVT’s scientific advisory board.