KALAMAZOO, Mich., Oct. 17 /PRNewswire/ -- Stryker Corporation (NYSE: SYK)
reported today that the U.S. Food and Drug Administration (FDA) granted it
Humanitarian Device Exemption (HDE) status for OP-1 Implant (Osteogenic
Protein 1). The clearance marks the first for a BMP in the United States.
Osteogenic Protein 1 is Stryker's patented recombinant protein, which induces
bone formation. The approved product, OP-1 Implant, is a combination of OP-1
and a collagen carrier. The product is wetted to form a paste which is then
surgically implanted in the fracture gap. The approved indication is for use
as an alternative to autograft in recalcitrant long bone nonunions where use
of autograft is unfeasible and alternative treatments have failed.
The approval marks the third regulatory clearance for OP-1 in a major
market following approvals earlier this year in Australia and the European
Union for specific trauma indications.
Under the HDE, OP-1 Implant will be made available as a humanitarian use
device, defined by the FDA as one intended to benefit patients by treating or
diagnosing a disease or condition that affects fewer than 4,000 individuals
per year in the U.S. HDE program information is available at
http://www.fda.gov/cdrh/ode/hdeinfo.html .
The commercial launch of the OP-1 Implant in the U.S. is expected to
commence later this quarter.
Stryker 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.
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SOURCE Stryker Corporation
Web site: http: //www.strykercorp.com
CONTACT: David J. Simpson, Vice President, Chief Financial Officer and Secretary of Stryker Corporation, +1-616-385-2600