Initially discovered in 1965 by Marshal Urist, BMPs are the only known proteins capable of inducing new bone formation. For over 20 years, Stryker has been dedicated to the research and development of BMP-7, also known as OP-1.
On October 17, 2001, the FDA approved OP-1 Implant under the Humanitarian Device Exemption (HDE) program. OP-1 Implant is now available across the country and is indicated for use as an alternative to the patients own bone (autograft) in recalcitrant long bone nonunions where autograft is unfeasible and alternative treatments have failed.
HUMANITARIAN DEVICE. OP-1 Implant is authorized by Federal law for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. The effectiveness of this device for this use has not been demonstrated.
What are BMPs?
BMP stands for bone morphogenetic protein. BMPs are members of the transforming growth factor beta (TGF-ß) superfamily of extracellular proteins. These factors act by binding to the cell’s exterior and transferring a signal to the nucleus via intracellular proteins called SMADs. This mechanism is essential in the formation and repair of a variety of tissue types including bone.
What is a Humanitarian Device Exemption?
A Humanitarian Device Exemption or HDE is an application to the Food and Drug Administration (FDA) that is a type of a pre-market approval (PMA) application, authorizing commercial marketing of a Humanitarian Use Device (HUD). The difference is that the HUD is exempt from the effectiveness requirements of a PMA.
A HUD is a device "intended to benefit patients in the treatment and diagnosis of diseases or conditions that affects or is manifested in fewer than 4,000 individuals in the United States per year."
A HUD also must be approved for use by a hospital's Institutional Review Board (IRB) before it can be used in patients for the designated indication(s). The IRB does not need to review and approve individual uses of an HUD.
What is OP-1?
OP-1 stands for Osteogenic Protein 1, which is also known as BMP-7. OP-1 is an osteoinductive growth factor specific to bone growth and formation. It actively recruits stem cells from the surrounding tissue and initiates the bone formation cascade. OP-1 is combined with a purified Type I collagen carrier to form OP-1 Implant. The collagen provides an osteoconductive scaffold on which the new bone can grow.
What is OP-1 Implant?
OP-1 Implant is an osteoinductive and osteoconductive bone graft material. OP-1 Implant is supplied in a glass vial containing one gram of the device in the form of a sterile dry powder comprised of bovine bone collagen and 3.3 mg of recombinant human Osteogenic Protein 1 (OP-1 or BMP-7). This is then combined with 2-3 cc of sterile saline to achieve the implantable product. The maximum human dose is 2 vials.
I am concerned about the overgrowth of bone. How do I know that OP-1 Implant will be contained at the fracture site and that there will not be bone formation outside the fracture site?
Good surgical practice, including containment of the device in the bony defect and proper soft tissue closure is essential to the safety and probable benefit of this device. Additionally, toxicology studies utilizing excessive doses of OP-1 have failed to show disseminated ectopic bone growth. The dosage of OP-1 has been carefully selected and refined in preclinical studies to provide a therapeutic dose while minimizing the occurrence of excessive bone growth at the site of implantation.
How do I know OP-1 Implant is safe?
In the US, OP-1 Implant is approved by the FDA under HDE regulations. The FDA has reviewed the preclinical and clinical data and has determined the probable benefits of using the product outweigh the associated risks. OP-1 Implant has demonstrated a consistent safety profile in clinical use since its launch in 2001. OP-1 Implant is approved in 28 additional countries, including Australia, Canada, and the European Union.
What are the long term results of OP-1 Implant?
OP-1 Implant has had excellent clinical results. As required by the indication listed on the FDA approval, cases treated with OP-1 Implant are recalcitrant long bone nonunions which have failed previous treatment or patients in which autograft (the current "gold standard" in fracture repair) is unfeasible for any number of reasons.
Other companies say they have BMPs in their product. What's new about OP-1?
OP-1 is a pure osteoinductive growth factor that actively recruits mesenchymal stem cells from surrounding tissue and initiates the bone formation cascade. It is a bone-specific growth factor, and is not a cocktail of growth factors or BMPs that include multiple components, some of which may be inhibitory to bone growth. While OP-1 Implant contains 3.3 mg of BMP-7, these other products contain negligible levels of BMPs, with questionable reliability, and possible efficacy, in providing consistent osteoinduction.