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ePharmaceuticals Cardio Topline by NewsEdge April 24, 2002

First Heart Valve Replacement Without Open Heart Surgery Experimental Device Developed By Percutaneous Valve Technologies May Provide Alternative to Open Heart Surgery In the United States
[PR Newswire]

FORT LEE, N.J., April 23 /PRNewswire/ via NewsEdge Corporation -- 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 www.pvtechnologies.com <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 open-heart surgery techniques currently used in valve replacement.

CONTACT:

Stanton Rowe

President & CEO

Percutaneous Valve Technologies, Inc.

201-363-8901

[email protected] <mailto:[email protected]>

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<http://tbutton.prnewswire.com/prn/11690X60574898>

SOURCE Percutaneous Valve Technologies, Inc. (PVT)

/CONTACT: Stanton Rowe, President & CEO of Percutaneous Valve Technologies, Inc., +1-201-363-8901, [email protected]/ <mailto:[email protected]/> /Web site: <http://www.pvtechnologies.com/>

<< Copyright ©2002 PR Newswire >>


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Applied Genetics News
Dec 19, 1999

CELL THERAPY: How to Grow a New Heart Valve.(Tepha Inc.)(Brief Article)

First make a heart valve-shaped scaffold out of biodegradable polymers. Then seed it with endothelial cells scavenged from an artery. Place the construct in an incubator and supply it liberally with culture medium. After about two weeks, the cells have completely covered the scaffold and are beginning to replace the scaffold with extracellular matrix. Voila! You have a heart valve ready to be implanted.

At the American Heart Association meeting, Simon Hoerstrup, a research fellow in John Mayer's laboratory at Children's Hospital, Boston, described how a heart valve incubator (bioreactor) had been developed to produce the new valves. By seeding cells onto a porous valve-like scaffold and subjecting the seeded scaffold construct to conditions in the incubator similar to those inside the heart, the researchers were able to produce functional tissue engineered heart valves.

The valves showed a close resemblance to native ones, and continued to grow and function after being transplanted into sheep. After 8 to 12 weeks the entire bioabsorbable scaffold was reported to have been resorbed and replaced with healthy cardiovascular tissue.

Patients receiving mechanical valve replacements must currently be placed on anticoagulant drugs and monitored for the rest of their lives to prevent blood clotting, and those receiving animal valves face the prospect of repeat surgeries as the performance of these valves begins to deteriorate. The new tissue engineered valves, however, are expected to be free from these problems. It is also hoped that the new technology will provide young children requiring heart valve replacement with a valve that can grow, removing the need for multiple surgeries to replace artificial implant valves as the child grows.

Previous attempts to engineer new tissue heart valves had been hindered by the lack of suitable bioabsorbable materials that could endure the repetitive bi-directional flexing of the heart valve leaflets. Simon Williams, president of Tepha, Inc. (303 Third St., Cambridge, MA 02142-1126; Tel: 617/492-0505 x216, Fax: 617/492-1996, Website: www. tepha.com), noted that the dual requirements of bioabsorption rate and mechanical properties were overcome using Tepha's proprietary technology. The company produced a flexible bioabsorbable material, known as PHA4400, to address these requirements and permit the fabrication of the heart valve scaffold.

Tepha is a recently formed spinout of Metabolix that is engaged in the development of a new range of bioabsorbable medical devices for therapeutic applications. The company is applying a core technology that allows it to engineer bioabsorbable polymers with properties suitable for use in a wide range of implantable products.


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