OP-1 sees some light in the USA:
Stryker Receives Humanitarian Device Exemption For
OP-1; Stryker's Patented Bone Morphogenetic Protein
(BMP) Is the First Approved in the U.S.
KALAMAZOO, Mich., Oct. 17 /PRNewswire/ -- Stryker Corporation (NYSE: SYK - news) 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 fda.gov .
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. |
