A 20 ml vial of OP-1 IMPLANT containing one gram of a sterile dry powder consisting of bovine collagen and 3.3 mg of rhBMP-7
Proven osteoinductivity and osteoconductivity*
Compatible with current surgical techniques in nonunion fracture repair
Contains collagen matrix, which is a good carrier for rhBMP-7*
OP-1 IMPLANT is ready for implantation immediately following reconstitution with saline
*Data is available on file
OP-1 IMPLANT is an osteoinductive and osteoconductive bone graft material. It is a combination of 3.3 mg of recombinant human BMP-7 (rhBMP-7) and 1 g of purified Type I bovine collagen, which is used as a carrier. The product is reconstituted with 2-3 cc of saline to form a paste which is then implanted at the nonunion site.
Please adhere to the following surgical technique
Preparation for use:
OP-1 IMPLANT is intended to be reconstituted with sterile Sodium Chloride (NaCl) Injection, 0.9%, USP solution (saline).
Using sterile technique, remove the vial from its packaging.
Lift the plastic flip-top and remove the crimp from the vial. Warning: Handle the crimp with care. The edges of the crimp are sharp and may cut or damage gloves.
Using your thumb, pry up the edge of the stopper. Once the vacuum is broken, remove the vial stopper while holding the vial upright to prevent loss of product. Warning: Do not insert a needle through the stopper. Puncture of the stopper with a needle may result in particles of the stopper material contaminating the device.
Carefully transfer contents of the OP-1 IMPLANT vial to a suitable container, such as a sterile bowl. Warning: To avoid breakage, do not tap the bottom of the vial when transferring contents.
Utilizing a sterile syringe, carefully add 2-3 cc of sterile saline to OP-1 IMPLANT in the container slowly and carefully.
Begin with 2 cc and add saline to desired consistency. Use of more than 3 cc will result in a less cohesive product which will be difficult to handle.
Mix the saline with the product using a sterile spatula or curette.
The reconstituted product will expand to a maximum volume (~4cc) within 2 minutes and has the consistency of wet sand.
Use the product promptly after reconstituting with saline.
The same procedure should be followed if a second vial of product is required.
Preparation of surgical site:
Step 1: Fracture Gap & Debridement
Debride fibrous, necrotic or sclerotic tissue and when appropriate decorticate bone so that the OP-1 IMPLANT can be in direct contact with bleeding bone and viable osseous tissue.
Step 2: Reduction & Irrigation
Apply selected fixation. Reduce the defect, irrigate and suction to ensure the surgical area is as ‘dry’ as possible.
Step 3: Hemostasis
Provide adequate hemostasis to ensure the material is not dislodged from the surgical site. Irrigate as necessary prior to the implantation of OP-1 IMPLANT. Where practical, surgical manipulations to the site should be completed prior to product implantation.
Step 4: Application & Closure
Remove the reconstituted OP-1IMPLANT from the container with a sterile instrument such as a spatula or curette. Apply the material to the prepared osseous tissue site.
The amount of material used should approximate the size of the bone defect.
Do not use suction or irrigation directly at the implant site as the particles of the product may be removed.
Remove excess fluid, if necessary, by suctioning adjacent to the implant site or carefully blotting the area with a sterile sponge.
Step 5: Close Soft Tissues
Close soft tissues around the defect containing the OP-1 IMPLANT using preferred suture material.
Closure is critical for containment of the implant in the area of the defect.
After closure of the soft tissues around the defect, irrigate field, if necessary, to remove any product which may have become dislodged during soft tissue closure.
Do not place drain directly at the implant site. If required, place it subcutaneously. Standard post-operative care should be followed. OP-1 IMPLANT will not appear on post-operative radiographs.
The surgical technique is shown for illustrative purposes only. Please see the package insert for the complete list of indications, warnings, precautions and other medical information.
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.
Brief summary of indications, contraindications and warnings:
OP-1 IMPLANT is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed.
OP-1 IMPLANT is contraindicated in patients who (1) are pregnant (2) have or have had a malignancy (3) are skeletally immature (4) are pregnant or want to become pregnant within 2 years of treatment (5) have a known hypersensitivity to the active substance or to collagen (6) have an autoimmune disease or immune suppression (7) have been previously treated with OP-1 IMPLANT or OP-1 PUTTY.
The use of OP-1 IMPLANT may result in (1) the formation of localized ectopic or heterotopic bone outside of the treatment site (2) development of an immune response againt BMP-7 or Type I collagen.
There are no adequate well controlled studies of OP-1 IMPLANT in (1) pregnant women (2) patients with autoimmune disease or immune suppression (3) patients with renal impairment.
Please see the package insert for the complete indication, contraindications, warnings, precautions, adverse events and other important medical information.
Caution: Federal law restricts this device to sale by or on the order of a physician.