IRVINE, Calif.–(BUSINESS WIRE)– MiCardia Corporation, a privately held medical device company, announced today that it has received the CE-Mark approval for commercial sales of its enCorSQ Mitral Valve Repair System in Europe and select countries worldwide. The enCorSQ 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 enCorSQ Mitral Valve Repair System is the only device available that can correct recurrent regurgitation without further surgical procedures.
“The MiCardia enCorSQ Mitral Valve Repair System is a leap forward in the surgical treatment of severe mitral regurgitation. It provides patients with a unique advantage that no annuloplasty ring does. Upon recurrent mitral regurgitation, in months following otherwise successful surgery, the MiCardia device can be activated in vivo resulting in a shape change of the device to treat recurrent regurgitation in a minimally invasive manner, avoiding often complex redo surgery. The enCorSQ device from MiCardia is a true paradigm shift in surgical repair of mitral regurgitation using annuloplasty rings,” says the company’s Chief Medical Officer, Dr. Maurice Buchbinder.
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 enCor products has been very promising. The enCorSQ Mitral Valve Repair System functions as a premium mitral repair device but has the unique capability to be adjusted with the Company’s proprietary enCor 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 enCorSQ provides a lower risk and more cost effective therapy for these patients,” says Don Rohrbaugh, the Company’s Chief Executive Officer.
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 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 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 SystemTM, 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 implanted in the EU since January, 2011.
The enCorSQ Mitral Valve Repair System is currently engaged in a confirmatory evaluation in six (6) 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. Micardia plans to begin a limited product launch of the enCorSQ in late 2011, followed by a broad launch in 2012.
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.