November 8, 2004
Percutaneous Edge-to-Edge Mitral
Shows Favorable Preliminary Results
Cath Lab Procedure Could Replace Major Heart Surgery
in Some Patients
(Philadelphia, PA and New Orleans, LA) – The
Hospital of the University of Pennsylvania (HUP)
is participating in a nationwide clinical trial of a
new valve repair device that could replace major heart
surgery in some patients. A tiny clip – delivered
by a catheter and deployed in the heart to repair a
malfunctioning and leaking mitral valve – is building
a favorable safety and feasibility profile as the EVEREST
Phase I clinical trial nears completion.
Severe mitral valve regurgitation (MR) is a debilitating
condition that causes shortness of breath, fatigue and
palpitations. In the United States, about 250,000 people
develop significant MR each year, with almost 50,000
requiring surgery. The clip is designed to secure the
valve’s leaflets near the center of the valve
so that blood leakage is minimized and the heart pumps
more efficiently. This new device could decrease a patient’s
hospital stay, result in fewer complications, provide
a quicker recovery time, and significantly reduce health
care costs. "In my most recently treated patient,
we utilized two clips to reduce his MR from severe to
mild. It has been six months since his procedure, and
he has no symptoms whatsoever,” says Howard
C. Herrmann, MD, Director of Interventional
Cardiology & the Cardiac Catheterization Laboratory
at Penn, and principal investigator for HUP’s
component of the EVEREST Trial.
“The development and clinical evaluation of this
device are paving the way for percutaneous, or through
the skin, valve repair. We are at the beginning of an
exciting new avenue in interventional cardiology. I
have no doubt that in five or ten years, interventional
cardiologists will be routinely treating valvular heart
disease in many patients without cardiac surgery,”
adds Dr. Herrmann.
To date, a total of 24 patients who suffered from significant
MR have received the clip as part of the EVEREST I clinical
study under an FDA-approved investigational device exemption
(IDE). The clip is a product of Evalve Inc., a medical
device company, and the sponsor of the trial. Based
on these promising results, a larger, Phase II safety
and efficacy trial may be initiated later this year.
Dr. Herrmann presented an update of the trial’s
findings today at the American Heart Association’s
Scientific Sessions 2004 in New Orleans during a presentation
entitled “Percutaneous Edge-to-Edge Mitral
Valve Repair: Preliminary Results of the EVEREST- I
To be eligible for the investigational procedure, candidates
must have moderate-to-severe or severe MR and be experiencing
symptoms (fatigue, chest pain, shortness of breath);
or, lacking these symptoms, they must have a weakened
left ventricle (heart muscle).
Performed in the cardiac catheterization lab, the initial
procedures have taken approximately two to four hours.
Under full anesthesia, a catheter (a thin, flexible
plastic tube) is introduced through the skin in the
thigh area and guided through the femoral vein to the
affected area of the heart. A smaller delivery catheter
that holds the clip is slipped through this tube so
that the clip can be guided into place and attached
to the leaflets (the “swinging doors”) of
the mitral valve. Once the clip is attached, the delivery
catheter is removed. The entire process is monitored
by an echocardiogram. The hospital stay has generally
been two nights; and most patients returned to normal
activity within one week.
Other investigators contributing to this study are Ted
Feldman, MD, Evanston Northwestern Healthcare System;
Hal Wasserman, MD, Columbia University Medical Center;
William Gray, MD, Swedish Medical Center, Seattle; Peter
Block, MD, Emory University Hospital and Patrick Whitlow,
MD, The Cleveland Clinic Foundation.
a printer friendly version of this release,
Caution: Investigational Device.
Limited by Federal (US) Law to Investigational Use
Editor’s Notes: Dr. Herrman receives
research funding from Evalve Inc.
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