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PERCLOSE ANNOUNCES PRELIMINARY RESULTS OF U.S. TRIAL FOR PROSTAR 9F AND 11F

MENLO PARK, Calif., March 27 /PRNewswire/ -- Perclose, Inc. (Nasdaq: PERC) announced today the preliminary results of the U.S. trial for the Prostar(TM) 9F and 11F Percutaneous Vascular Surgical systems which confirmed the devices' safety and efficacy. The findings were presented today at the American College of Cardiology meeting in Orlando, Florida by Richard Kuntz, M.D., MSc., director of the Cardiovascular Data Analysis Center (CDAC) at Beth Israel Hospital of Harvard Medical School in Boston, Massachusetts.

The study compared the use of the Perclose system with mechanical compression, the traditional method of arterial access site management, in procedures following balloon angioplasty and stenting. The 500 patient randomized study showed that the average time to ambulation was significantly reduced with the Prostar system than with the compression method (13.6 vs. 25.8 hours). "This is the first closure device study that has demonstrated no significant difference in major complications while substantially reducing time to hemostasis and ambulation," said Dr. Kuntz. "Additionally, the ninety-five percent procedure success rate with no late stage complications supports the strategy of earlier patient discharge in future clinical applications," Dr. Kuntz continued.

Not only does the reduced time to ambulation with the Prostar system dramatically improve patient comfort but it also contributes to the reduction of hospital resources due to a decreased need for nursing observation. Because of the Prostar's suture-based technology, the use of this system for arterial access site closure allows patients to receive uninterrupted anticoagulation and new anti-platelet drug therapies, such as Centacor/Eli Lilly ReoPro, which protect the patients' arteries in the heart from life threatening blood clots.

"We are very pleased with the positive preliminary results of the trial for the Prostar 9F and 11F systems as this is the first FDA closure device trial which shows a clear patient benefit in reduction of time to ambulation," said Hank Plain, Perclose's president and chief executive officer. "The trial results demonstrate that the arterial access site can be closed safely, immediately following coronary interventions such as balloon angioplasty, regardless of sheath size, even in fully anticoagulated patients."

Perclose, Inc., based in Menlo Park, California, is a technology leader in the development and commercialization of suture-based closure devices for arterial access site management. The company's proprietary Prostar and Techstar systems are designed to offer less-invasive, cost-effective alternatives, providing the patient with significant clinical benefits including rapid hemostasis, earlier ambulation and improved patient comfort. The Prostar 9F and 11F systems, the Prostar Plus 8F system and the Techstar 6F, 7F and 8F systems are currently being marketed internationally. Perclose's common stock is traded on the Nasdaq National Market under the symbol PERC.

For more information on Perclose, Inc. at no cost, call 800-PRO-INFO.
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/CONTACT: Hank Plain, President and Chief Executive Officer of Perclose, Inc., 415-473-3100; or Ann Trunko (general information), or Anne Geary (analyst contact), 415-986-1591, both of Financial Relations Board, for Perclose/

(PERC)

CO: Perclose Inc. ST: California, Florida IN: MTC SU: PDT

SM -- SFW012 -- 2683 03/27/96 15:00 EST
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Publication:PR Newswire
Date:Mar 27, 1996
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