IRVINE, Calif.--(BUSINESS WIRE)--MiCardia® (MiCardia Corporation, Irvine, California) today announced the completion of the first U.S. implant of its Dynaplasty® mitral valve repair technology. The surgery was performed last week at Beaumont Hospital, Royal Oak, Michigan. Francis L. Shannon, M.D., who is a partner in SEMCVS and Director of CV Surgical Research and Quality Outcomes at Beaumont, commented, “The MiCardia® device implanted easily and conformed well to the patient’s mitral annulus. The complete D-shaped ring was used to reinforce a complex repair of a flail leaflet segment using minimally invasive techniques. We are excited to be participating in the DYANA Study and believe Dynaplasty® technology will address a major weakness of current devices, namely their inability to deal with changes in valve shape and function after the initial repair procedure.”
Commenting on the first U.S. site to enter the study, MiCardia® Chief Executive Officer Paul Molloy said, “This is a major milestone for MiCardia® and we are grateful for Dr. Shannon’s expertise in helping develop this technology. The Dynamic Annuloplasty Activation study involves patients from Europe who receive a device capable of activation post-implant and patients from the U.S. who receive a shape memory device that is not capable of activation. MiCardia® received a 510(k) clearance on the non-active version of its Dynaplasty® System in September 2008. Patient data from both the U.S. and Europe will be submitted toward CE Mark of the Company’s Dynaplasty® devices this year. We expect to complete enrollment and submit six month follow up data from the DYANA Study in Q4 of 2009 as a prelude to European commercialization of the world’s first minimally invasive, beating heart valve repair system.”
MiCardia® is developing Dynaplasty® technology for the treatment of structural heart disease, focusing initially on mitral and tricuspid valve disorders and as a method of interrupting a major element in the onset and progression of Heart Failure. More than 15m people in Europe and the U.S. are in Heart Failure, of which more than 7m suffer from mitral regurgitation.
MiCardia® is a privately held company, founded in 2004 and is developing a completely unique treatment technology that will allow minimally invasive late stage adjustment of cardiac anatomy. Surgical, transcutaneous and entirely non-invasive activation platforms are in advanced development.
The MiCardia Dynamic Annuloplasty System is not currently available in the USA. Clinical evaluation is in progress. Not available for sale. MiCardia®, Dynaplasty® and Dynamic Annuloplasty System are registered trademarks of MiCardia Corporation. All rights reserved.
Contact:
MiCardia® Mr. Paul Molloy Chief Executive Officer 949-951-4888 pmolloy@MiCardia.com
