KALAMAZOO, Mich., Jan. 29 /PRNewswire/ -- Stryker Corporation (NYSE: SYK)
reported today that it received a Not-Approvable Letter from the Food and Drug
Administration (FDA) regarding its Pre-Market Approval (PMA) for OP-1
Implant(TM) for use in treating nonunion fractures of the tibia. Stryker had
filed its PMA on June 7, 1999. The deficiencies cited relate primarily to the
lack of statistical equivalence as compared to the control treatment of
autograft in the clinical trial for tibial nonunions. The FDA has recommended
that Stryker conduct a new study. Stryker intends to continue to pursue
approval and seeks to hold a meeting with the FDA shortly to discuss the
letter.
As previously reported, the Committee for Proprietary Medicinal Products
(CPMP) has adopted a unanimous positive opinion to recommend the granting of
marketing authorization for OP-1 as a drug in the European Union. Stryker has
an application for market approval still pending in Australia and expects to
be reviewed by the ADEC (Australian Drug Evaluation Committee) later this
quarter.
Stryker Corporation develops, manufactures and markets specialty surgical
and medical products, including orthopaedic reconstructive, trauma, spinal and
craniomaxillofacial implants, powered surgical instruments, endoscopic
systems, patient care and handling equipment for the global market and
provides outpatient physical therapy services in the United States.
SOURCE Stryker Corporation
Web site: http: //www.strykercorp.com
CONTACT: David J. Simpson, Vice President, Chief Financial Officer and Secretary of Stryker Corporation, 616-385-2600