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| [January 22, 2013] |
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MiCardia Corporation Receives Notification of a New German Reimbursement Code for the Adjustment of Its enCorSQ Mitral Valve Repair System
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
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.
About MiCardia
MiCardia is a privately held medical device company in Irvine, CA (News - Alert). 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.
For further information about MiCardia and enCorSQ,
please visit www.micardia.com
or contact: Robin Gibbs Director of Communications
and Marketing +949-951-4888 rgibbs@micardia.com
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.

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