News | February 20, 2009

MiCardia Announces Worlds’ First Dynamic Heart Valve Repair on a Beating Heart

February 20, 2009 - MiCardia Corp. this week announced the worlds’ first dynamic adjustment of the mitral valve annular geometry on a beating heart.

This marks the first dynamic adjustment of the MiCardia’s new Dynaplasty mitral valve repair technology in the Company’s European Dynamic Annuloplasty Activation (DYANA) Study, designed to provide data for CE Mark of the company’s Dynaplasty Technology.

The procedure was performed by Professor Hans-Joachim Schafers, director of thoracic and cardiovascular surgery, Saarland University Hospital, Homberg, Germany earlier this month.

“MiCardia’s Dynaplasty Technology was implanted in a standard surgical approach to correct an MVR of +3,” Dr. Schafers said. “Post-operative residual MR was corrected by remotely activating the device. This is the first time annular geometry has been adjusted to eliminate MVR in a beating heart. It represents a major step forward in technology”.

Francis Shannon, M.D., a leading cardio-thoracic surgeon at Southeastern Michigan Cardiovascular Surgeons in Troy, Michigan, and also a scientific advisor to MiCardia explained, “The potential of Dynaplasty technology to non-invasively adjust the shape of devices implanted in the heart to improve the performance of the cardiac cycle is a major breakthrough in cardiovascular care. To my knowledge, MiCardia is the only company developing intra-operative, percutaneous and completely non-invasive dynamically adjustable devices for both mitral and tricuspid valve repair.”

The company expects to complete enrollment and submit six-month follow up data from the DYANA Study in 2009 as a prelude to European commercialization of the system.

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 US 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).

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