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MiCardia DYANA Clinical Study Interim Results Highlighted at 23rd Annual Meeting of the European Association for Cardio-Thoracic Surgery.

IRVINE, Calif. -- MiCardia Corporation today announced that a scientific presentation of the interim results of the Dynamic Annuloplasty Activation (DYANA) Clinical Study was presented by Professor Ottavio Alfieri at the 23rd Annual Meeting of the European Association for Cardio-Thoracic Surgery held in Vienna, Austria in October 2009.

During the scientific presentation, Professor Alfieri, Chief of Cardiac Surgery at San Raffaele University Hospital, Milan, Italy and principal investigator of the DYANA Study commented, "The introduction of an adjustable prosthetic ring in the surgical armamentarium for mitral valve repair definitely represents a valuable addition to the current technology. The concept of 'dynamic' annuloplasty, strictly related to the use of an adjustable ring, is very attractive for the surgeon and potentially beneficial for the patient."

MiCardia's Dynaplasty Technology platform treats residual and recurrent valve regurgitation by making it possible to adjust mitral and tricuspid valve leaflets of the heart long after the initial implant. This dynamic adjustment will be done as an outpatient procedure, on a beating heart. No such option exists for these sufferers of valve regurgitation today.

The DYANA Study included thirty-six patients implanted with MiCardia's patented shape memory Dynaplasty mitral repair system, thirty-one enrolled at four European centers and five at William Beaumont Hospital in the US, the latter implanting a non-activation version of the device. Of the European implants, eight were successfully activated for correction of residual mitral regurgitation post-operatively.

Commenting on the future potential of Dynaplasty Technology, Professor Alfieri said, "Ultimately, MiCardia will provide a range of transcutaneous and externally activated devices that are reversible, adjustable as often as required and that will allow continuous re-tuning of the mitral and tricuspid valve to match the ongoing geometric changes of the heart. This provides the physician with a previously unavailable second chance to optimize the annuloplasty not only before the patient leaves the operating room, but also when the patient returns for control."

The DYANA Study was designed to support submission for CE mark of the firm's Dynaplasty[R] Dynamic Annuloplasty System in Europe. The Company plans to apply for CE Mark of its first Dynaplasty[R] product and then add "late stage" activation capability to its devices.

MiCardia is a privately held company, founded in 2004 and is developing the unique Dynaplasty Technology for the treatment of structural heart disease which will allow adjustment of cardiac anatomy both intra-operatively and post-operatively. Surgical, percutaneous 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.
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Publication:Business Wire
Article Type:Clinical report
Date:Nov 10, 2009
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