Healthcare Industry News: RF Generator
News Release - September 15, 2011
A Unique Treatment for Recurrent Mitral Regurgitation Eliminates the Need for High Risk Redo Surgery
First patient is successfully treated with MiCardia’s enCorSQ deviceIRVINE, Calif.--(Healthcare Sales & Marketing Network)-- MiCardia Corporation, a privately held medical device company, announced today that an enCorSQ Mitral Valve Repair System(TM) patient in Stuttgart, Germany was the first to undergo treatment for recurrent mitral valve regurgitation (MR) without the need for a high risk surgical re-operation. The patient was surgically implanted with an enCorSQ device in April, 2011, and, in August, presented with significant recurrent mitral regurgitation. Dr. Markus Czesla, of Sana Herzchirurgie in Stuttgart, was able to adjust the enCorSQ device through a small incision and significantly reduce the level of regurgitation in less than one minute. The patient was released from the hospital the next morning. Until now, recurrent mitral regurgitation had to be ignored, treated medically or corrected with another higher risk, open surgical procedure.
“The 45 second activation has become a smart and novel option to treat progressive heart failure after surgery and is a breakthrough in mitral valve surgery,” says Dr. Czesla.
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 for which the enCorSQ Mitral Valve Repair System can provide a lower risk option for correction, weeks or months post implantation.
“This adjustment confirms the fundamental concept of the enCorSQ and demonstrates that with a minimally invasive procedure, the shape of the implanted device can be changed to effectively reduce 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 enCorSQ, provides a lower risk and more cost effective therapy for this class of patient,” says Don Rohrbaugh, the company’s Chief Executive Officer.
MiCardia Corporation has begun initial marketing activity for the enCorSQ Mitral Valve Repair System in the EU. Since the beginning of 2011, MiCardia’s first device, the enCor Mitral Valve Repair System, has been available for sale in Germany, Italy and Austria.
“This is a historic development in our ability to treat patients with recurrent regurgitation following initially successful surgical correction. This minimally invasive approach will undoubtedly improve acute and long term outcomes in this difficult to treat patient subset. I am extremely gratified with these early results,” says Dr. Maurice Buchbinder, Chief Medical Officer for MiCardia.
About Mitral Regurgitation
Mitral Regurgitation, 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.
What is Non-Surgical Mitral Adjustment?
The MiCardia enCorSQ Mitral Valve Repair System is a mitral repair device with a permanently attached lead and a proprietary energy source, the MC-100 RF Generator. The enCorSQ 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 using conventional surgical techniques 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 small cut-down. The lead is then connected to its energy source, the MC-100. 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 enCorSQ
MiCardia is a privately held medical device company, currently marketing its intra-operative device, the enCor Mitral Valve Repair System(TM), in the European Union. The intra-operative device allows the surgeon to address any residual MR or coaptation correction, real-time, off-pump, on a beating heart. The enCor Mitral Valve Repair System has been available for sale in the EU since January, 2011.
The enCorSQ Mitral Valve Repair System is currently engaged in a confirmatory evaluation in multiple hospitals in the European Union. This device allows the surgeon to address any recurrent MR or coaptation correction with an off-pump, minimally invasive procedure days-to-months post-implant.
The company is also developing a unique, trans-catheter device, enCorTC, which will provide the capability to implant the mitral annuloplasty device interventionally. The enCorTC catheter delivery, anchoring system and annuloplasty device will provide a totally non-surgical, lower risk method for treating mitral valve regurgitation.
The MiCardia enCor Mitral Valve Repair System and the enCorSQ Mitral Valve Repair System are not currently available for sale in the USA. MiCardia, DynaplastyTM, enCor Mitral Valve Repair System(TM) and enCorSQ Mitral Valve Repair System(TM) are registered trademarks of MiCardia Corporation.
Source: MiCardia
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