Paracor Medical Announces Award of CE Mark

Tue Jun 3, 2008 7:00am EDT

* Reuters is not responsible for the content in this press release.

SUNNYVALE, Calif.--(Business Wire)--
Paracor Medical, Inc. announced today that it has received CE mark
approval from its notified body, BSI, for the initial two products
based upon its HeartNet(TM) technology platform. The approval will
allow the expanded use of Paracor's HeartNet and HeartNet-D products
to treat patients suffering from systolic heart failure within the
member countries of the European Union.

   The HeartNet implant, an elastic nitinol structure, provides
support to the walls of the heart's pumping chambers, the ventricles.
This elastic support augments the function of the heart, and is
designed to attenuate or reverse the negative remodeling, or
enlargement, associated with the advanced stages of heart failure. The
second product, HeartNet-D, incorporates defibrillation electrodes
within the elastic structure of the device, providing the potential to
address arrhythmia problems that can be life-threatening to heart
failure patients. The HeartNet-D is compatible with the leading
commercially available implantable defibrillation systems. Both
products are delivered in a procedure typically lasting about one hour
through a less invasive mini-thoracotomy approach, avoiding some of
the problems associated with cardiac procedures that employ an open
chest or sternotomy procedure.

   The CE mark application was approved based upon clinical studies
assessing the impact of HeartNet and HeartNet -D therapy in more than
fifty patients. The studies indicated that, on average, treated
patients experienced statistically significant improvements in
structural parameters (left ventricular end systolic and diastolic
diameters, left ventricular volumes), exercise parameters (6 minute
walk), and quality of life measures (Minnesota Living with Heart
Failure instrument) through six months of follow-up, with continuing
positive trends at the twelve month time frame. In addition, patients
treated with the HeartNet-D therapy maintained appropriate
defibrillation safety margins through six months of follow-up testing.

   In commenting on the CE mark certification, William G. Mavity,
Paracor Medical's President and CEO, noted, "We are extremely pleased
to have succeeded in obtaining this significant approval, as it
indicates compliance with applicable development, manufacturing and
quality standards that are recognized globally. Over the coming
months, we will be considering appropriate strategies to enable the
Company to leverage the CE mark status of our products and broaden the
clinical acceptance of the HeartNet therapy."

   Paracor Medical is currently evaluating the HeartNet therapy in an
FDA approved clinical trial in North America that intends to enroll
more than 270 treatment and control patients. Designated PEERLESS-HF
(Prospective Evaluation of Elastic Restraint to LESSen the effects of
Heart Failure), the trial will compare the impact of the HeartNet
treatment plus optimal medical and device therapy, per current
guidelines, to results in patients who continue to receive optimal
therapy alone.

   The American Heart Association estimates that 5.3 million U.S.
persons have been diagnosed with heart failure, with more than 500,000
newly diagnosed patients each year. Heart failure is a leading cause
of U.S. hospital admissions, and only about half of heart failure
patients will survive more than five years. A European survey
indicated that 10 million people suffer from heart failure in
countries represented by the European Society of Cardiology.

   Paracor Medical, Inc. is a venture capital financed medical
technology company focused on the development of a platform of
technologies and products to treat heart failure. Based in Sunnyvale,
CA, the company was founded in 1999. Its website is

Paracor Medical
William Mavity, 408-734-6030
Chief Executive Officer

Copyright Business Wire 2008
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