Evalve Announces Enrollment Completion Of The EVEREST Randomized Study

Evalve, Inc., the leader
in the development of devices for the percutaneous repair of cardiac
valves, announced the completion of randomized enrollment in the
Endovascular Valve Edge-to-Edge REpair STudy (EVEREST), which is evaluating
the MitraClip(R) system as a non-surgical repair option for patients
suffering from mitral regurgitation (MR). MR is the most common type of
heart valve insufficiency in the United States, affecting millions of
people worldwide.



"The completion of enrollment in the randomized trial is an important
milestone for the field of cardiology," said Ted Feldman, M.D., director of
the cardiac catheterization lab at Evanston Northwestern Hospital and
co-principal investigator of the trial. "It is the first randomized trial
of any percutaneous mitral repair device compared to mitral valve surgery,
and also the first large prospective evaluation of current mitral valve
surgery using an independent core laboratory."



EVEREST is a U.S. Food and Drug Administration (FDA) approved Phase II
randomized, controlled, multi-center clinical research study in the United
States and Canada evaluating the safety and efficacy of the MitraClip
device in 279 patients with moderate-to-severe (3+) or severe (4+) MR, as
compared to surgical repair or replacement. The study effectiveness
endpoint requires an MR reduction to less than or equal to 2+ at one year.
The primary effectiveness endpoint is freedom from surgery for valve
dysfunction, death, and moderate-to-severe or severe mitral regurgitation
at 12 months. The primary safety endpoint is freedom from major adverse
events (MAE) at 30 days or hospital discharge whichever is longer.



Evalve received CE Mark approval for the MitraClip device earlier this
year and the first series of patients were recently treated in Germany. The
MitraClip system is the only commercially available treatment alternative
that enables non-surgical repair for MR.



"Randomized trials provide valuable insight into directing future
studies to improve therapy and match new therapies to the appropriate
patient," said Donald Glower, M.D., professor of surgery at Duke Medical
Center and co-principal investigator of the EVEREST study. "This trial sets
a high scientific standard for future percutaneous valve therapies. As a
result, this trial will have a significant and long-lasting impact on
patient care around the world."



Overall, EVEREST Investigators have treated more than 350 patients with
over 450 MitraClip devices implanted. Clinical data continues to grow and a
significant number of three-year follow up results are available as well as
four-year data from a smaller group of patients.



Registry data from the initial non-randomized cohort of EVEREST
patients continue to indicate MR reduction is maintained over time in the
majority of patients, hospital stays are short, fewer complications occur
compared to mitral valve surgery and surgical options are preserved if
needed.
















More information about the EVEREST trial is available at
mitralregurgitation.



"This is an important achievement for Evalve on the path to meeting
regulatory milestones with the FDA," said Ferolyn Powell, president and
chief executive officer of Evalve. "We believe the MitraClip system has the
potential to provide patients suffering with MR an important alternative to
surgery that will allow them to avoid the associated risks and trauma."



About the MitraClip Procedure



Percutaneous mitral repair with Evalve's MitraClip device is performed
by physicians in the catheterization laboratory. The heart beats normally
during the procedure, and therefore does not require a heart-lung bypass
machine. In addition to improving blood flow through the heart, the
procedure may also relieve symptoms such as fatigue and shortness of breath
that often affect patients with significant MR. After treatment, patients
generally recover quickly. The MitraClip device may improve quality of life
and may help MR patients avoid or delay surgery, having preserved surgical
options (valve repair or replacement) should surgery become necessary.



About Evalve, Inc.



Founded in 1999, Evalve, Inc. -- headquartered in Menlo Park,
California -- has developed a proprietary system which enables percutaneous
repair of cardiac valves. The company's initial products are intended to
reduce the risks, trauma and costs associated with current open, arrested
heart surgical options. For more information about Evalve, Inc., and for an
animated explanation of the percutaneous mitral repair procedure using the
MitraClip device, visit evalveinc. Evalve is the first
portfolio company from the medical device company incubator, The Foundry
(thefoundry).



The MitraClip system is currently undergoing clinical evaluation in the
United States and Canada.



MitraClip and Evalve are registered trademarks of Evalve, Inc.


Evalve, Inc.

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