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Perclose Submits PMA Application for Prostar 9F And 11F Systems

MENLO PARK, Calif., Nov. 26 /PRNewswire/ -- Perclose, Inc. (Nasdaq: PERC) today announced that it submitted a Pre-market Approval (PMA) application to the United States Food and Drug Administration (FDA) for approval of its Prostar(TM) 9F and 11F Percutaneous Vascular Surgical systems for commercial sale in the United States. The PMA submission to the FDA incorporated data from a 500 patient, randomized multi-center Investigational Device Exemption (IDE) clinical trial that was completed in March 1996.

Hank Plain, Perclose's president and chief executive officer commented, "We now feel we are well positioned for regulatory review of the Prostar 9F and 11F systems. The FDA has indicated that it would review the PMA application on an expedited basis. However, there is no assurance that the FDA will review this submission in any specific time frame."

The Prostar 9F and 11F are minimally invasive surgical systems used to close arterial access sites following therapeutic catheterization procedures such as angioplasty and stenting. The clinical study submitted with the PMA application compared the use of the Perclose systems with mechanical compression, the traditional method of arterial access site management, in procedures following balloon angioplasty and stenting. The 500 patient, multi-center, randomized IDE clinical trial of Perclose's arterial closure device demonstrated a statistically significant reduction in median time from procedure to ambulation (from 20.5 hours to 7.7 hours) and a reduction in median time to hemostasis of the arterial access site (from 6.4 hours to less than 25 minutes) with no significant increase in major complications.

The Company believes that not only does the reduced time to ambulation with the Prostar system improve patient comfort but it also contributes to the reduction of hospital resources due to a decreased need for nursing observation. Perclose's suture-based technology for arterial access site closure is intended to allow patients to receive continuous anticoagulation and new anti-platelet drug therapies which help protect the patient's coronary arteries from life threatening blood clots.

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

The matters discussed in this news release relating to the regulatory status of the Prostar systems are forward looking statements that involved risk and uncertainties, including the receipt and timing of regulatory approvals (particularly PMA approval for the Prostar systems), availability and market acceptance of new products, and the management of growth.

For more information on Perclose, Inc. at no cost, call 800-PRO-INFO.

SOURCE Perclose Inc.
 -0- 11/26/96

/CONTACT: Ken Ludlum of Perclose, Inc., 415-473-3100, ext. 278; or general information, Ann Trunko, or analysts, Kate Rajeck, 415-986-1591, both of Financial Relations Board, for Perclose/


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

CW-KW -- SFTU015 -- 4192 11/26/96 08:31 EST
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Publication:PR Newswire
Date:Nov 26, 1996
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