SAN RAMON, Calif. -- (BUSINESS WIRE) -- BioVentrix, an emerging medical device company, announced today that it has appointed Noel Messenger as Vice President of Regulatory & Clinical Affairs.
Mr. Messenger joins BioVentrix from Santa Clara, Calif.-based Guided Delivery Systems, where he has served since March 2007 as Vice President of Regulatory Affairs & Quality Assurance for the percutaneous heart valve repair company. Prior to Guided Delivery Systems, Mr. Messenger was Vice President of Clinical and Regulatory Affairs & Quality Assurance at TriVascular from 2003 to 2007. The aortic and thoracic aneurysm repair company was acquired by Boston Scientific in 2005.
“With the recent regulatory approval for our initial product, the Revivent Myocardial Anchoring System, and a second, transcatheter product expected to launch in 2013, the addition of Noel to our leadership team, further increases our Company’s successful momentum,” said Kenneth Miller, president and chief executive officer of BioVentrix. “Noel’s experience includes obtaining approvals to initiate CE-mark clinical trials in Europe, Canada, and South America for unique heart valve technology. In addition, Noel has managed a pilot clinical study in Germany and managed the successful completion of two FDA 510(k)s for clearance of diagnostic catheters.
“Our innovative Revivent system is designed to empower cardiac surgery teams not only to ensure optimal clinical outcomes and enhance quality of life for heart failure patients but also to do so with very minimal risk compared to the existing gold standard of conventional left ventricular reconstructive surgery,” added Mr. Miller. “While we are pleased with the European regulatory approval of Revivent, we also are looking forward to Noel spearheading approval of our next-generation Revivent technology — TransCatheter Ventricular Restoration (TCVR). Given the successful clinical outcomes we already have achieved with Revivent, we have fast-forwarded development of our next-gen technology designed to achieve the same results, but with a sternal-sparing technique. This endovascular, beating heart, transcatheter therapy is expected to be a new paradigm for treating heart failure patients, holding great promise for those who have suffered a heart attack but are just too sick to tolerate invasive heart surgery. Certainly, Noel Messenger will play a key role in the clinical development and regulatory pathway for our transcatheter product, which is designed to be a hybrid technology for use by cardiologists and cardiac surgeons.”
The Revivent™ Myocardial Anchoring System makes possible Less Invasive Ventricular Enhancement™ (LIVE™), a procedure that excludes scarred ventricular tissue caused by a heart attack and restores the heart to a more optimal, conical shape, thereby enhancing performance of the non-damaged myocardium and improving quality of life. Currently, reshaping of the left ventricle requires an invasive procedure known as surgical ventricular restoration (SVR), performed by stopping a beating heart with the use of cardiopulmonary bypass, where significant incisions into the heart muscle are made to excise the scarred, non-functioning ventricular tissue. The invasive nature of SVR limits the number of patients for whom the procedure may be performed due to the fragile nature of this patient population. In contrast, the less invasive LIVE™ procedure using the Revivent™ system is performed without the need of cardiopulmonary bypass or making incisions into the heart.
BioVentrix, a privately held medical technology company headquartered in San Ramon, Calif., is focused on developing and commercializing minimally invasive as well as nonsurgical therapies for treating heart failure (HF).
NOTE: The Revivent™ Myocardial Anchoring System is approved for sale in Europe; it is not approved in the U.S.