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Experimental Device Developed By Percutaneous Valve Technologies May Provide Alternative to Open Heart Surgery

PRNewswire

Percutaneous Valve Technologies,
Inc. (PVT) — a privately held medical technology company engaged in the
development of a breakthrough device for the treatment of aortic stenosis —
announced today that its less invasive aortic valve procedure was performed in
a cardiac catheterization laboratory, for the first time, avoiding open-heart
surgery to treat senile aortic stenosis, a narrowing of the heart valve. This
first clinical case was performed on April 16, 2002, by Dr. Alain Cribier, the
chief of cardiology at the University of Rouen Hospital, Charles-Nicolle in
Rouen, France. Next year clinical trials on this experimental device are
expected to begin in the United States.

“The 57 year old male patient that received the aortic valve procedure,
developed by Percutaneous Valve Technologies, had a failing heart and was
refused for surgery by three surgical teams because of his deteriorating
condition and complicated vascular disease,” said Dr. Cribier. “Lacking any
other clinical solution for this patient, the PVT valve was a life saving
technology. We are pleased to be the world’s first clinical site to utilize
this breakthrough technology. This technology represents a new frontier in
interventional cardiology.”

The PVT device is a proprietary blend of balloon-expandable stent
technology with a bioprosthetic valve made from biological tissue. The
procedure deploys the stent across the old valve, holding it permanently open
allowing for replacement of the old stenotic valve with a new one, thus
removal of the failing valve is not required. This technology may be
applicable to therapeutic conditions including the treatment of mitral
stenosis, aortic regurgitation and venous insufficiency.

Dr. Cribier continues, “The patient’s blood pressure returned to normal
almost immediately, and his heart performance has improved dramatically. The
PVT valve has proven many important principles today, including precise
placement and anchoring, hemodynamic performance, and the acute improvement of
heart function. This will be a very important option for non-surgical and
high-risk patients with aortic stenosis. “

“Severe aortic stenosis is a disease that requires replacement of the
valve in a highly invasive surgery,” said Dr. Martin Leon, Lenox Hill Hospital
in New York, NY. “The ability to perform this procedure in a cath lab as
demonstrated in this first patient is a historic event in cardiology, ranking
with the first stent implantation in a human almost 20 years ago.”
“This case was the world’s first human implant of an aortic heart valve in
the cardiac cath lab,” said Stanton Rowe, president and chief executive
officer, Percutaneous Valve Technologies. “There are many patients with aortic
stenosis who are not good candidates for surgery who could benefit from this
less invasive option. Many of these patients are debilitated with no options
but intensive medical therapy, which fails to improve their heart function.”
Aortic stenosis is a narrowing of the heart valve that causes the heart to
work very hard to eject blood into the body. It results in shortness of
breath, and in advanced cases, may result in fainting and heart failure.
Symptomatic patients are typically treated by surgery.

Over 300,000 patients every year have surgery on their heart valves. Sixty
percent of valve replacement surgeries are for the aortic valve. Aortic
stenosis occurs predominantly in an elderly population, many over 70 years of
age. These patients are at higher risk of surgical complications and many have
other complicating illnesses.

For more information about PVT, visit their Web site at
http://www.pvtechnologies.com.

About PVT
Percutaneous Valve Technologies, Inc. (PVT) located in Fort Lee, NJ, with
a subsidiary in Israel, is a privately held medical technology company
developing an innovative, percutaneous approach for delivering heart valves to
treat late-stage aortic stenosis. This less invasive device, designed by PVT,
is a proprietary blend of balloon-expandable stent technology with a
bioprosthetic valve made from biological tissue. The procedure deploys the
stent across the old valve, holding it permanently open allowing for
replacement of the old stenotic valve with a new one, thus removal of the
failing valve is not required. It is designed to be delivered in a cardiac
catheterization laboratory under local anesthesia, using fluoroscopic
guidance, thereby avoiding general anesthesia and highly invasive; Q3n-heart
surgery techniques currently used in valve replacement.

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