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CARBOMEDICS HEART VALVE APPROVED FOR SALE IN THE UNITED STATES

 AUSTIN, Texas, Sept. 30 /PRNewswire/ -- CarboMedics, Inc. received notification today from the U.S. Food and Drug Administration (FDA) that their Pre-Market Approval (PMA) application had been satisfied for the new CarboMedics Prosthetic Heart Valve (CPHV). The bileaflet CPHV can now be supplied to medical centers in the United States directly without restriction. The approval represents the culmination of an extensive multi-center clinical study which was initiated in September, 1987, to establish the safety and efficacy of the valve.
 Since the first implant of the CPHV on Dec. 18, 1986, more than 60,000 implants have been performed worldwide by 1500 cardiac surgeons in 55 countries at 970 open heart centers. Throughout this experience, as well as during the study carried out to fulfill the PMA, the valve has demonstrated an exemplary clinical performance and has proven to be safe and durable with no structural failure reported. Certain advanced features have been incorporated into the design of the valve to simplify insertion, improve patient safety and enhance functional assessment. These benefits have accelerated the acceptance of the CPHV worldwide.
 The CPHV consists of a Pyrolite(R) Carbon orifice and leaflets. The pure Pyrolite Carbon orifice is reinforced with a titanium stiffening ring to protect it from deformation and structural failure. Unlike any other bileaflet valve available in the United States, the CPHV is rotatable. The valve is also considered to have a low profile in comparison to previously used valves. It also incorporates a polyester sewing ring that is coated with Biolite(R) Carbon.
 The CPHV is manufactured by CarboMedics, Inc., a company of Sulzermedica. CarboMedics, headquartered in Austin, is the world's most fully integrated source of enhanced heart valve technology and a leading manufacturer of Pyrolite Carbon components. The company is comprised of two segments; a proprietary heart valve group and an original equipment manufacturer (OEM) specializing in biomaterial research, development and manufacturing.
 CarboMedics is one of nine medical device companies that make up Sulzermedica. The partnership of companies focuses on the development of implantable medical devices and biomaterials for the cardiovascular, orthopedic and dental implant markets. Sulzermedica employs 3,600 people worldwide and is owned by Sulzer Limited which is headquartered in Winterthur, Switzerland.
 -0- 9/30/93
 /CONTACT: Perry Barrs of CarboMedics, 512-873-3323, or Michele Golden of Fellers & Company, 512-338-4500/


CO: CarboMedics, Inc. ST: Texas IN: MTC SU:

SH -- NY071 -- 7345 09/30/93 13:49 EDT
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Publication:PR Newswire
Date:Sep 30, 1993
Words:400
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