December 18, 2008 - MiCardia announced the successful implant in two patients with the new new Dynaplasty mitral valve repair technology at the department of cardiovascular surgery, University Hospital, Kiel, Germany, the first week of December.
This marks the commencement of the company’s European Dynamic Annuloplasty Activation (DYANA) Study designed to provide data for CE Mark of the company’s Dynaplasty technology.
“This is a new generation of dynamic repair device. It implanted easily using a conventional approach and the patients are doing well,” said professor Jochen Cremer M.D. Ph.D., who leads the cardiac surgery team at the University Hospital. “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.”
MiCardia received a 510(k) clearance on the static version of its Dynaplasty System in September 2008 and implants will commence shortly at several centers in the U.S. The company plans to submit U.S. implant data as part of its European CE Mark submission and in turn capture critical clinical data from its European DYANA Study to support regulatory submissions and commercialization of its systems in the U.S.
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 congestive heart failure (CHF).
The MiCardia Dynamic Annuloplasty System is not currently available in the USA. Non-US clinical evaluation is in progress. Not available for sale. MiCardia, Dynaplasty and Dynamic Annuloplasty System are registered trademarks of MiCardia Corporation. All rights reserved.
For more information: www.MiCardia.com