CARBOMEDICS BEGINS MARKETING CPHV BILEAFLET PROSTHETIC HEART VALVE

CARBOMEDICS BEGINS MARKETING CPHV BILEAFLET PROSTHETIC HEART VALVE in the U.S. following FDA approval Sept. 30. The company received the FDA go-ahead to market the bileaflet pyrolitic carbon mechanical valve five and a half months after the agency's circulatory system devices panel unanimously recommended the device for approval ("The Gray Sheet" April 19, p. 4). The valve represents a new challenge to St. Jude, which sells the only other bileaflet valve on the U.S. market. Some analysts are discounting the threat to St. Jude posed by the CarboMedics prosthesis due to the established safety record of the St. Jude device. Rachael Scherer, in a July 29 Dain Bosworth research capsule, contended that St. Jude's safety record is its "trump card." She pointed out that the "CarboMedics valve, among others, has been competing against the St. Jude valve in markets outside of the [U.S.] for quite some time -- and St. Jude is still the leader in those markets, with a growth rate last quarter of approximately 20% in non-U.S. markets." Companies currently marketing bileaflet valves overseas include ATS and Sorin as well as St. Jude and CarboMedics. Over 60,000 CarboMedics valves have been implanted worldwide since December 1986. The firm says that "throughout this experience...the valve has demonstrated an exemplary clinical performance and has proven to be safe and durable with no structural failure reported." The new valve, which is approved for use in aortic and mitral positions, represents CarboMedics" debut in the U.S. heart valve market. The firm had originally sought approval to market the prosthesis as a replacement for mitral, aortic, tricuspid and pulmonic cardiac valves. The FDA approval letter covers three models of the CPHV: the A500 for aortic applications, the R500 with a "reduced sewing ring" for aortic applications and the M700 for mitral applications, as well as related accessories. The A500 is available in nine sizes from 16 mm to 31 mm; the R500 in six sizes from 19 mm to 29 mm; and the M700 in five sizes from 25 mm to 33 mm. The letter also calls for a postapproval followup study. Despite having some unique features, the CPHV should be priced competitively with the St. Jude bileaflet device, according to CarboMedics. The CPHV consists of a pyrolitic carbon orifice assembly, two pyrolitic carbon coated valves with a graphite substrate, and a polyester cloth sewing ring incorporating a titanium band. The CPHV, unlike the St. Jude prosthesis, has valves that can be rotated in the orifice assembly for ease of valve positioning. The device also has a low profile compared to other prostheses, the company says. "These benefits have accelerated [the] acceptance of the CPHV worldwide," the company says. A subsidiary of Sulzermedica, CarboMedics plans to market the device in the U.S. through a combination of distributors, direct sales reps and independent commissioned sales agents. The firm expects to see an immediate impact on sales in the fourth quarter of the year (beginning Oct. 1).