IRVINE, Calif.--(BUSINESS WIRE)--MiCardia Corporation announced today it has received notification that a new German reimbursement code has been approved for the adjustment of the Company’s enCorSQ Mitral Valve Repair SystemTM. This new code will provide additional reimbursement for the enCorSQ, a breakthrough approach to the long-term treatment of mitral valve disease. In particular, this new code will reimburse the follow-up treatment of recurrent mitral regurgitation which statistically occurs in 15-30% of all patients with surgically repaired mitral valves. The Company believes that the enCorSQ System is the only available technology that provides such follow-up therapy for the heart’s mitral valve.
Don Rohrbaugh, MiCardia’s CEO, indicated, “This new code completes the reimbursement procedures for the enCorSQ in Germany and serves as a model for other European healthcare systems. Existing codes reimburse mitral valve repair, which continues to be the preferred surgical treatment for mitral valve regurgitation. This new code reimburses enCorSQ’s unique feature which allows the surgeon to adjust the implant to address recurrent regurgitation with a short, minimally invasive procedure. To date, adjustments have been successfully completed as late as 13 months post initial implant.”
This new reimbursement code is available for all hospitals in Germany to cover the costs associated with the enCorSQ adjustment procedure and is in addition to the reimbursement paid for the enCorSQ implantation procedure.
MiCardia’s enCorSQ is an annuloplasty device to treat Mitral Regurgitation (MR) with unique features that enable the physician to adjust the device at a later date without another surgery. This late adjustment capability corrects recurrent mitral valve regurgitation that results from the progressive nature of the underlying cardiovascular disease. The late 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 may experience recurrence of mitral valve regurgitation depending upon the etiology of the disease. 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.
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.
MiCardia is a privately held medical device company in Irvine, CA. The Company is currently marketing its enCorSQ Mitral Valve Repair System in the European Union. The enCorSQ 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 enCorSQ Mitral Valve Repair System has been available for sale on a limited basis in the EU since January, 2012.
The MiCardia enCor Mitral Valve Repair SystemTM and the enCorSQ Mitral Valve Repair SystemTM are not currently available for sale in the USA. MiCardia, DynaplastyTM, enCor Mitral Valve Repair SystemTM and enCorSQ Mitral Valve Repair SystemTM are registered trademarks of MiCardia Corporation. All rights reserved.