Micardia corporation receiv.

MiCardia Corporation Receives CE Mark Clearance to Market enCor™ .
MiCardia Corporation Receives CE Mark Clearance to Market enCor™ Dynamic Mitral
Valve Repair System in the European Union
IRVINE, Calif.--(BUSINESS WIRE)--MiCardia Corporation announced today that it has received the CE Mark to begin
marketing the Company’s enCor™ Mitral Valve Repair System in the European Union.
The enCor device offers unique benefits to patients and physicians during mitral valve repair “We thank the clinical
surgery, a procedure to address mitral regurgitation, performed annually on thousands of investigators who
patients worldwide. The enCor device provides a physician a device that can dynamicallyadjust the mitral value annulus to correct any residual mitral valve regurgitation intra- participated in the
operatively, in real-time on a beating heart (off-bypass-pump). In the European Union Company’s DYANA study
approximately 20,000 mitral valve repair procedures are performed annually.
that provided the clinical
data that validate enCor’s
“Obtaining the CE Mark approval for MiCardia’s first product is a significant milestone towardsdeveloping the Company’s marketing infrastructure, which will be initially focused in the ability to reduce mitral
European Union. The enCor Mitral Valve Repair System has been presented and widely valve regurgitation.”
accepted in several EU medical meetings this past fall,” said Don Rohrbaugh, the company’sChief Executive Officer.
Samuel Shaolian, the Company’s co-founder and Chief Technology Officer, said, “We thank the clinical investigators whoparticipated in the Company’s DYANA study that provided the clinical data that validate enCor’s ability to reduce mitral valveregurgitation.” He added, “Our next generation, enCorSQTM, will enable clinicians to dynamically adjust the device in a minimallyinvasive manner, to correct recurrent mitral valve regurgitation due to the progression of the underlying cardiovascular disease,weeks or months post implantation. Many experts believe the enCor will be a breakthrough in the treatment of mitral valvedisease.” About Mitral Regurgitation
Mitral regurgitation (MR), the most common type of heart valve insufficiency, occurs when the heart's mitral valve does not closeproperly. Both the American Heart Association and the American College of Cardiology recommend open-heart surgery to repairor replace the mitral valve for patients who suffer from moderate-to-severe (Grade 3+) and severe (Grade 4+) MR; open heartsurgery is not recommended for patients with Grade 1 to 2+ MR. An estimated four million people in the United States havesignificant (>2+) MR, with an annual incidence of 250,000 newly diagnosed patients.
About MiCardia and enCor
MiCardia is a privately held medical device company currently preparing for the commercialization of its first series of products,enCor™, in the European Union. enCor is a unique device that is surgically implanted to treat mitral valve regurgitation. enCorutilizes the company’s patented technology, Dynaplasty™, to provide a ‘second chance’ for the surgeon to adjust the ringdynamically to correct residual regurgitation.
MiCardia Corporation Receives CE Mark Clearance to Market enCor™ .
The company is also developing a unique, second generation product, the enCorSQ. The enCorSQ can be activated to reshapethe mitral valve annulus to resolve regurgitation, minimally invasively, weeks, months or years later, without the need for the riskand cost of redo surgery. A clinical study on the enCorSQ is planned for early 2011.
Currently in development is the Company’s enCorTC, which will provide the capability to implant the Dynaplasty Technologyinterventionally. The enCorTC will be delivered via a catheter delivery and anchoring system, providing a totally non-surgical,lower risk method to treat mitral valve regurgitation.
For further information, please visit www.micardia.com.
The MiCardia enCor Dynamic Annuloplasty System is not currently available for sale in the USA. MiCardia, Dynaplasty, enCor and enCor Mitral Valve Repair System are registered trademarks of MiCardia Corporation. All rights reserved.
MiCardia Corporation
Robin Gibbs
Director of Communications and Marketing
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Source: http://www.micardia.com/pdf/11-03-10-MiCardia-Corporation-Receives-CE-Mark-Clearance-to-Market-enCor.pdf

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