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MiCardia Corporation’s enCorSQ Mitral Valve Repair SystemTM Presented During the “Mitral Days Heart Surgery Symposium” in Stuttgart, Germany

Thu, 10/04/2012 - 8:00am
The Associated Press

IRVINE, Calif.--(BUSINESS WIRE)--Oct 4, 2012--MiCardia Corporation, a privately held medical device company, announced today that a scientific presentation and live surgery of the en CorSQMitral Valve Repair System were presented at the 2 nd Mitral Days Heart Surgery Symposium in Stuttgart, Germany to 200 cardiac surgeons and professionals.

Dr Martin Andreas from the Department of Cardiac Surgery at the Medical University of Vienna presented a paper on “The Benefit of Adjustable Annuloplasty Rings” and further described the University’s experience with the en CorSQ. The University of Vienna, under the leadership of Professor Dr Gunther Laufer and Professor Dr Alfred Kocher has one of the leading European experiences with the implantation and adjustment of the en CorSQ.

Dr Markus Czesla from the Department of Cardiac Surgery at the SANA Heart Center in Stuttgart performed a live surgical implant of the en CorSQ utilizing a minimally invasive right thoracotomy, which was transmitted to the audience in 3D. In addition, Dr Czesla performed a live adjustment of the en CorSQ. The 65 year patient had experienced a recurrence of regurgitation after 6 months post implant. It should be noted that 15-30% of mitral repair patients have recurrent regurgitation within the first year. Once the device was adjusted, the patient’s moderate (MR 2 – 3) regurgitation was reduced to mild (MR1) in less than one (1) minute. The Stuttgart SANA Heart Center, under the leadership of Professor Dr Nicolas Doll has one of the most extensive experiences with the implantation and adjustment of the en CorSQ.

The en CorSQ device is surgically implanted to treat Mitral Regurgitation (MR) and enables the physician to adjust the device without another surgery to correct any recurrent mitral valve regurgitation that may occur due to the progressive nature of the underlying cardiovascular disease. The adjustment can be achieved, weeks to months post implantation without the need for a repeat high risk surgical procedure. In the European Union, approximately 20,000 mitral valve repair procedures are performed annually. Up to 30% of those patients will experience recurrence of mitral valve regurgitation. To the Company’s knowledge, the en CorSQMitral Valve Repair System is the only device available that can correct recurrent regurgitation without further surgical procedures.

"The en CorSQ provides a unique advantage over other annuloplasty rings. Until now, recurrent mitral regurgitation could only be treated medically or with re-do surgery. With the MiCardia device, recurrent regurgitation can be reduced or eliminated, minimally invasively, without complex redo surgery. This device offers a patient management solution that has otherwise not been available," says Professor Dr Alfred Kocher of the University of Vienna, on his  en CorSQ experiences.

About Mitral Regurgitation Mitral Regurgitation (MR), mitral insufficiency or mitral incompetence, the most common type of heart valve disorder, occurs when the heart’s mitral valve does not close properly resulting in an inadequate blood flow to the body. It is the abnormal leaking of blood from the left ventricle, through the mitral valve, and back into the left atrium when the left ventricle contracts.

Both the American Heart Association (AHA) and the American College of Cardiology (ACC) recommend open-heart surgery to repair or replace the mitral valve for patients who suffer from moderate (Grade 3+) to severe (Grade 4+) mitral regurgitation. Both the AHA and ACC guidelines recommend repair as the operation of choice. An estimated four million people in the United States have significant (>2+) MR, with an annual incidence of 300,000 newly diagnosed patients. Similar incidence of MR exists within the European Union.

“Experience to date with the Company’s en Cor products has been very promising. The en CorSQMitralValve Repair System functions as a premium mitral repair device but has the unique capability to be adjusted with the Company’s proprietary MC-100 RF generator, to increase coaptation of the leaflets and address recurrent mitral regurgitation. Currently, to effectively treat recurrent regurgitation, a repeat open-heart surgery with a heart/lung bypass procedure is required. This promising new approach with the en CorSQ provides a lower risk and more cost effective therapy for these patients,” says Don Rohrbaugh, the Company’s Chief Executive Officer.

en Cor SQ and Non-Surgical Mitral Adjustment The MiCardia en CorSQMitral Valve Repair System is a mitral repair device with a permanently attached lead and a proprietary energy source, the MC-100 RF generator. The en CorSQ is constructed using a memory shape alloy core that has been designed to change its shape when its temperature is elevated a few degrees above body temperature. The device is implanted on the mitral annulus and the permanent lead is tunneled through the atrial wall and implanted under the skin in the chest or abdominal cavity.

If mitral regurgitation recurs, days to months after the initial procedure, the permanent lead is exposed in a minimally invasive manner, using a surgical cut-down. The lead is then connected to the en CorSQ energy source. The shape of the device is changed, thereby reducing the anterior posterior distance of the mitral valve and eliminating or minimizing the recurrent regurgitation.

About MiCardia and en Cor SQ MiCardia is a privately held medical device company in Irvine CA. The Company is currently marketing its en CorSQMitral Valve Repair SystemTM, in the European Union. The en CorSQ device allows the surgeon to address any recurrent MR or coaptation correction, real-time, off-pump, on a beating heart, days or months after the surgical implant. The en CorSQMitral Valve Repair System has CE market clearance and has been available for clinical use in the EU since January, 2012.

For further information about MiCardia and en CorSQ, please visit www.micardia.com.

CONTACT: MiCardia Corporation Robin Gibbs Director of Communications and Marketing +949-951-4888 rgibbs@micardia.com KEYWORD: UNITED STATES EUROPE NORTH AMERICA CALIFORNIA GERMANY INDUSTRY KEYWORD: SURGERY HEALTH CARDIOLOGY MEDICAL DEVICES OTHER SCIENCE SCIENCE SOURCE: MiCardia Corporation Copyright Business Wire 2012 PUB: 10/04/2012 08:00 AM/DISC: 10/04/2012 08:00 AM http://www.businesswire.com/news/home/20121004005343/

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