Study Shows Device Offers A Non-Surgical Solution To Mitral Regurgitation
CardiAQ Valve Technologies (CVT) discloses successful results of acute in vivo study of its Transcatheter Mitral Valve Implantation (TMVI) System
WINCHESTER, Mass., Sept. 28, 2009-Transcatheter heart valve company CardiAQ Valve Technologies (CVT), which is developing the world's first self-conforming and self-anchoring technology for Transcatheter Mitral Valve Implantation (TMVI), announced that successful results of an acute in vivo study of its TMVI system were disclosed by Dr. Joseph Bavaria, Vice Chief of Cardiothoracic Surgery at the Hospital of Pennsylvania at University of Pennsylvania during the "Mitral Valve Therapies Prior to and in Human Investigation" program at the "Transcatheter Cardiovascular Therapeutics (TCT) 2009" annual scientific meeting.
Dr. Bavaria reported five major outcomes of the acute in vivo study of TMVI: (1) accurate positioning of the implanted valve relative to the mitral valve annulus; (2) secure anchoring of the implanted valve to the mitral anatomy without relying on radial force; (3) preservation of the subvalvular apparatus; (4) conformance of the implanted valve to the mitral annulus to prevent paravalvular leaks; and (5) confirmation of a clear, unobstructed Left Ventricular Outflow Tract (LVOT).
"Without question, there is an enormous unmet clinical need for the vast majority of patients suffering from mitral regurgitation," said Dr. Bavaria. "In fact, about 80-90% of MR patients suffer from functional MR, a hugely untreated segment of the market that is often too sick to undergo surgery and for whom surgical repair has already been shown to be largely ineffective with recurrent rates of MR around 20%.
On the other hand, TMVI offers the potential for a non-surgical solution that could be more effective than transcatheter repair and just as effective as surgical replacement," added Dr. Bavaria. "With TMVI, it appears that simple access along with controlled placement could allow for truly interventional or non-surgical procedure characteristics, and therefore the existing shortcomings of surgical mitral valve replacement may be mitigated."
"We are very pleased with the preclinical data presented by Dr. Bavaria at TCT 2009, and we look forward to continued success in the development of our TMVI technology as we move toward chronic in vivo studies," said J. Brent Ratz, CVT's President and CEO.
Dr. Joseph Bavaria is the Brooke Roberts/William Maul Measey Professor of Surgery and Director of the Thoracic Aortic Surgery Program for the University of Pennsylvania Health System. He has published extensively on issues regarding thoracic aortic surgery, lung transplantation, and circulation management for complex thoracic aortic reconstruction. Dr. Bavaria serves as Chairman of CVT's Scientific Advisory Board (SAB).