Healthcare Industry News: mitral valve
News Release - September 19, 2008
Cardiac Dimensions(R), Inc. Announces Key Personnel ChangesMr. Paul Cornelison and Mr. Nawzer Mehta Join Senior Management
KIRKLAND, Wash.--(HSMN NewsFeed)--Cardiac Dimensions®, Inc. is pleased to announce two important additions to its senior management team. Mr. Paul Cornelison recently joined the company as Vice President of Regulatory Affairs and Quality Assurance. In addition, Mr. Nawzer Mehta, Ph.D., has joined the company as Vice President of Clinical Affairs.
Mr. Cornelison comes to Cardiac Dimensions from Arrow International, a medical device company that manufactures critical care and cardiac assist devices. While there, he held numerous senior management positions within the Regulatory Affairs/Quality Assurance arena. Most recently, Mr. Cornelison was vice president of Regulatory Affairs for the Asia International business. Prior to Arrow, he held key regulatory positions at St. Jude Medical, Angeion Corporation and Telectronics Pacing Systems. Mr. Cornelison will be responsible for all worldwide regulatory filings, and will coordinate the company’s U.S. and international product approval efforts.
Mr. Mehta joins Cardiac Dimensions from Northstar Neuroscience, where he served as Vice President of Clinical Affairs. During this time he led clinical studies in both the United States and Europe, and worked closely with the Food and Drug Administration on the company’s key clinical strategies. Prior to Northstar, Mr. Mehta led clinical efforts at Medtronic, Biotronik and Corazonix. Mr. Mehta will take the lead in establishing Cardiac Dimensions’ pivotal trial strategy and execution for the CARILLON™ Mitral Contour System™.
“We are very excited to have both of these quality individuals on board and I know Paul and Nawzer look forward to working with our entire team to help advance our innovative therapy to the next level and ultimately address a huge unmet clinical need,” commented Rick Stewart, Cardiac Dimensions’ President and CEO.
Approximately 5 million people in the U.S. and over 20 million people worldwide suffer from Heart Failure. Most of these patients also suffer from dilated cardiomyopathy and FMR; the majority of whom are inadequately treated using medical management. While surgical options exist and can be effective in reducing FMR, they are infrequently used due to the burden of the surgery itself, which can be associated with high operative morbidity and mortality rates.
The CARILLON™ Mitral Contour System™ combines a proprietary implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors. It is delivered percutaneously via jugular access under fluoroscopic guidance. The implant is designed to be positioned, adjusted and gently anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve, thereby reducing mitral regurgitation. Preclinical and early clinical data have suggested both a reduction in mitral regurgitation and improvements along other key parameters including NYHA (New York Heart Association) class, 6 Minute Walk Times and Quality of Life.
Cardiac Dimensions®, Inc., based in Kirkland, Washington, develops and manufactures devices designed for treating heart failure and related conditions.
For further information contact Tom Douthitt at (425) 605-5900 or visit Cardiac Dimensions®, Inc. website at www.cardiacdimensions.com
Source: Cardiac Dimensions
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