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NEW PROSTHETIC HEART VALVE IN FINAL PHASE OF FDA APPROVAL PROCESS; CARBOMEDICS' NEW HEART VALVE CLOSE TO FDA APPROVAL TO ENTER U.S. MARKET

 AUSTIN, Texas, Sept. 2 /PRNewswire/ -- The CarboMedics Prosthetic Heart Valve (CPHV), a second generation low profile bileaflet mechanical prosthesis intended for replacement of human cardiac valves, is close to completion of the final approval process of the U.S. Food and Drug Administration. The valve is designed and manufactured by CarboMedics, Inc., a company of Sulzermedica.
 The unique aspect of the CPHV is that it is made of Pyrolite(R) Carbon and it is rotatable within a titanium reinforcement ring and allows imaging after implantation and maximum blood flow in the patient. The CPHV is currently used for implants in Europe, and a total of 60,000 international implants have been completed. CarboMedics estimates final commercial approval and distribution of the CPHV will begin by the end of this year.
 Following the FDA's Circulatory Devices Advisory Review Panel's unanimous "recommendation for approval" in April, the FDA issued CarboMedics an "approvable letter" dated July 1, 1993, stating that clarifications were required before a final approval phase was to be completed for the CPHV. CarboMedics has since successfully completed the necessary responses for the FDA and passed the FDA's prerequisite Good Manufacturing Practice (GMP) inspections in its Canadian and U.S. manufacturing facilities.
 "We are appreciative of the overwhelming support and acceptance of the CPHV from the international community, and the FDA's diligence in their review, and are looking forward to serving the heart valve needs within the United States," according to Perry Barrs, vice president/general manager of the Proprietary Business Segment of CarboMedics.
 CarboMedics, headquartered in Austin, is the world's most fully integrated source of enhanced heart valve technology and a leading manufacturing of Pyrolite(R) Carbon components. The company is comprised of two segments; a proprietary heart valve group and an original equipment manufacturer (OEM) specializing in biomaterial development and manufacturing.
 CarboMedics is one of nine medical device companies that make up Sulzermedica, a global partnership of companies focused on the development of implantable medical devices and biomaterials for the cardiovascular, orthopedic, and dental implant markets worldwide. Sulzermedica is owned by Sulzer Limited with headquarters in Winterthur, Switzerland and employs 3,600 people worldwide.
 -0- 9/2/93
 /CONTACT: Michele Golden of Fellers & Company, 512-338-4500, or Perry Barrs of CarboMedics, 512-837-3323/


CO: CarboMedics ST: Texas IN: MTC SU:

MP -- NY055 -- 8413 09/02/93 12:14 EDT
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Publication:PR Newswire
Date:Sep 2, 1993
Words:388
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