MiCardia Announces First U.S. Implant

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Tue Jun 16, 2009 6:01pm EDT

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. 



MiCardia
Mr. Paul Molloy
Chief Executive Officer
949-951-4888
pmolloy@MiCardia.com

Copyright Business Wire 2009

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