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Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System

December 4, 2008

MENLO PARK, Calif., Dec. 4 /PRNewswire/ — Long-term data published in
EuroIntervention showed that the expected decrease in Mitral Vale Area (MVA)
after repair with the MitraClip(R) system to correct mitral regurgitation (MR)
is not associated with clinically significant mitral stenosis. Additionally,
with two years of follow-up, none of the patients treated with the
MitraClip(R) system required surgery for mitral stenosis. At 12 months no
important differences were reported between the use of one or two MitraClip(R)
devices or based on the etiology of MR.

The analysis was conducted to assess diastolic mitral valve function after
percutaneous repair. Echocardiographic measurements of MVA and mean trans-
Mitral Valve Gradient (MVG) were made in 96 patients implanted with the
MitraClip(R) device. Patients were followed for up to two years.

The MitraClip(R) system is the first commercially available medical device
which provides a non-surgical mitral valve repair option for patients
suffering from the effects of MR. The MitraClip(R) system is available
commercially in Europe and is currently in late stage clinical trials in the
United States
.

MR affects millions of people worldwide and is the most common type of
heart valve insufficiency in Europe and in the United States. The vast
majority of patients with significant MR are untreated, which leaves their
hearts affected by the chronic volume overload caused by MR, requiring the
heart to work harder, and ultimately leading to heart failure.

“It is important to know that the encouraging results from use of the
MitraClip(R) system were maintained at two years without mitral stenosis,”
said Howard C. Herrmann, M.D., director, Interventional Cardiology and Cardiac
Catheterization Laboratories at the hospital of the University of Pennsylvania
and lead author of the manuscript. “With these results, we have a growing body
of evidence that MitraClip(R) therapy can be a good option for many patients
in the right situation.”

The MitraClip device creates a double orifice mitral valve by securing the
leaflets to reduce MR in a replication of the surgical procedure pioneered by

Ottavio Alfieri, MD. The resulting double orifice has an inherently smaller
cross sectional area compared to the native mitral valve. In a preliminary
study published in Catheterization and Cardiovascular Interventions in 2006,
Dr. Herrmann and colleagues demonstrated a similar decrease in MVA using the
MitraClip(R) system also without causing mitral stenosis. In the present
analysis, these observations were extended to a larger study population with
longer term follow up, and included patients who received more than one
MitraClip(R) device and those with functional MR.

The study population for the present analysis included 107 patients with
moderate-to-severe or severe MR who were enrolled in the EVEREST phase I
registry (n=55) or subjects who were not randomized as part of the EVEREST II
trial (n=52).

Baseline characteristics and hemodynamic measurements were analyzed for
the 96 patients in the study population who received the MitraClip(R) device.
All patients were either symptomatic (91 percent) or if asymptomatic had
evidence of left ventricular dysfunction.

Transthoracic echocardiography was performed at baseline, pre-discharge,
one year and two year follow-up and analyzed by an independent core
echocardiographic laboratory at the University of California at San Francisco.

The mean MVA as measured by planimetry decreased from 6.0 +/- 1.3 cm at
baseline to 3.6 +/-1.2 cm (p<0.05) at discharge. At 12 months MVA was 3.6 +/-
1.2 cm (n= 59). The mean MVG increased from 1.7 +/- 0.9 mmHg at baseline to
4.1 +/-2.2 mmHg (p<0.05) at discharge. At 12 months MVG was 3.4 +/-1.6 mmHg
(n=50). From discharge to 24 months, there were no significant changes in the
mean MVA or MVG. There were no differences in mean MVA or MVG at 12 month
follow up between patients who received one MitraClip(R) device (69 percent)
and those receiving two MitraClip(R) devices (31 percent). Patients with
functional MR had a slightly smaller mean MVA, both at baseline and at
discharge, but did not differ from degenerative MR patients at later follow-
up. These hemodynamic results are consistent with reports of surgical edge-to-
edge repair which also have shown that diastolic mitral valve function is
preserved.

“These longer-term results contribute to the existing body of clinical
data regarding the performance of this first in class, less invasive treatment
approach. We are pleased that Dr. Hermann and the coauthors have reported
this important information so that it is available for physicians to discuss
with their patients as they consider this non-surgical treatment option” said

Ferolyn Powell, president and chief executive officer of Evalve.

About the MitraClip(R) Procedure

Percutaneous mitral repair with Evalve’s MitraClip(R) system 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(R) therapy 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 procedure using the MitraClip(R) device, visit
www.evalveinc.com. Evalve is the first portfolio company from the medical
device company incubator, The Foundry (www.thefoundry.com).

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

MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.

SOURCE Evalve, Inc.


Source: newswire



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