MitraClip Device Preliminary Data Suggests Improved Heart Function and Relief from...

Tue Apr 1, 2008 11:31am EDT

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MitraClip Device Preliminary Data Suggests Improved Heart Function and Relief
from Heart Failure Symptoms in Functional Mitral Regurgitation Patients
Study Continues to Show Lasting Reductions in Mitral Regurgitation Across a
Spectrum of Patients

CHICAGO, April 1, 2008 /PRNewswire/ -- Percutaneous mitral repair using
the MitraClip(R) device may successfully reduce mitral regurgitation (MR) in
patients suffering from functional MR (FMR) over a two-year period, according
to preliminary data from the ongoing Endovascular Valve Edge-to-Edge REpair
STudy (EVEREST) presented today at the SCAI Annual Scientific Sessions in
Partnership with the ACC i2 Summit (SCAI-ACCi2). The EVEREST trial is
evaluating the safety and efficacy of the MitraClip device for the treatment
of MR, a condition in which blood leaks backward through the mitral valve,
requiring the heart to work harder and ultimately leading to heart failure.
    The data analysis was based on 23 patients with moderate-to-severe or
severe FMR (grade 3+ to 4+). James Hermiller, M.D., director of the
interventional fellowship program at St. Vincent Heart Center of Indiana in
Indianapolis, presented the findings. Dr. Hermiller reported that 83 percent
of the 23 FMR patients had successful MR reduction after the MitraClip
procedure. Additionally, the majority (74 percent) of successfully treated FMR
patients showed MR reduction to less than or equal to  2+ MR. Importantly, the
MR reduction was maintained, with a Kaplan-Meier durability of MR reduction in
89 percent of patients at one and two years.
    "The results have surpassed our initial expectations," said Dr. Hermiller.
"This compelling preliminary data suggests that the treatment of functional MR
with the MitraClip may be an effective option for patients."
    Other results, showed that at one year, clinical symptoms improved or
stabilized compared to baseline in 92 percent of successfully treated FMR
patients (matched data, n=12). Symptomatic relief was seen in 70 percent of
FMR patients who had a history of heart failure.
    In addition to the reduction in MR severity and clinical symptoms, left
ventricular function significantly improved in successfully treated FMR
patients, as defined by objective measures indicating significant reverse left
ventricular remodeling at one year.
    All 23 FMR patients were discharged home with self-care after a mean
length of stay of 3 days -- a contrast to surgical treatment which often
requires more extensive in-hospital stays and post-discharge care through
in-home nursing or a step down facility. While the minimally-invasive nature
of the MitraClip procedure is expected to preserve standard surgical options
for patients should they be necessary, 83 percent of the FMR patients were
surgery free at a median follow-up of one year following the MitraClip
procedure.
    "It is generally well accepted that percutaneous interventions provide
safer and less traumatic options for patients. We are very pleased with the
low complication rate and percutaneous observed in the initial percutaneous
mitral valve repair procedures," said Ferolyn Powell, president and chief
executive officer of Evalve. "The reduction of MR with durable results and
improved heart function highlight the potential of the MitraClip device. We
believe we are making strides with a new, less-invasive method of valve repair
for both functional MR and degenerative MR patients."
    About Mitral Regurgitation
    MR is the most common type of heart valve insufficiency, affecting more
than 4 million people in the United States. There are 250,000 new significant
MR diagnoses each year; however only 20 percent, or approximately 50,000, of
these patients undergo surgery each year. The other 200,000 remain affected by
the chronic volume overload caused by MR, which requires the heart to work
harder, ultimately leading to heart failure.
    Additionally, an estimated 5 million people in the U.S. are diagnosed as
suffering from heart failure. Approximately half of these patients suffer from
Functional MR which is associated with a significantly increased risk of
mortality.
    About EVEREST
    The EVEREST study continues at more than 40 centers in North America with
more than 300 patients treated and nearly 400 MitraClip devices implanted to
date. Investigators are currently enrolling patients in the randomized arm of
the study with the goal of completing enrollment by the end of 2008.
    Enrollment in the study is open to several patient groups:
    -- Patients with either degenerative or functional MR
    -- Patients who are good surgical candidates and are open to the option of
       a less invasive approach
    -- Patients who are higher risk surgical candidates but are considered
       operable

    More information about the EVEREST II trial is available at
www.mitralregurgitation.org
    About the MitraClip Procedure
    Percutaneous mitral repair with Evalve's MitraClip device is performed by
interventional cardiologists 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 potentially avoid or delay surgery, having
preserved surgical options (valve repair or replacement) should surgery become
necessary.
    About Evalve, Inc.
    Evalve, Inc. (Menlo Park, Calif.) was incorporated in 1999 to design,
develop, manufacture, and market innovate devices to enable 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. The company's present development and clinical efforts
are focused on mitral valve repair. For more information about Evalve, Inc.,
and for an animated explanation of the Percutaneous Mitral Repair procedure
using the MitraClip device, visit www.evalveinc.com. Evalve is the first
portfolio company from the medical device company incubator, The Foundry
(www.thefoundry.com).
    MitraClip and Evalve are registered trademarks of Evalve, Inc.
SOURCE  Evalve, Inc.

Heather Harper, of Edelman, +1-415-533-1001 (Cell),
heather.harper@edelman.com
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