Compatible with current surgical techniques in posterolateral lumbar fusion (PLF)
Contains collagen matrix, which is a good carrier for rhBMP-7*
OP-1 PUTTY is readily moldable and ready for implantation immediately following reconstitution with saline
*Data is available on file
OP-1 PUTTY is an osteoinductive and osteoconductive bone graft material. OP-1 PUTTY consists of the recombinant human BMP-7 (rhBMP-7), Type I Bovine Bone Collagen Matrix (collagen matrix) and the Putty Additive carboxymethylcellulose sodium (CMC). OP-1 PUTTY is intended to be reconstituted with sterile saline (0.9%) solution.
OP-1 PUTTY is provided as 2 units. Each unit is comprised of:
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 OP-1
A 10 mL vial of Putty Additive containing 230 mg of sterile carboxymethylcellulose (CMC)
One vial of OP-1 IMPLANT and one vial of Putty Additive must be combined with sterile saline to produce one unit of OP-1 PUTTY. One unit of OP-1 PUTTY will be used for each side of the spine.
Please adhere to the following surgical technique
Preparation for use:
One unit of OP-1 PUTTY (1 vial OP-1 IMPLANT/1 vial Putty Additive) will be used on each side of the spine. The patient will receive a total of 6.6 mg of OP-1 per bilateral posterolateral revision fusion.
Using sterile technique, remove the vials from their packaging.
Lift the plastic flip-top and remove the crimp from the OP-1 IMPLANT vial and the smaller vial containing the Putty Additive. 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. After the vacuum is broken, remove the stopper from each vial 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 and PUTTY ADDITIVE 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 2.5 cc of sterile saline (0.9%) to the sterile container slowly and carefully.
Gently stir the contents of the container with a sterile spatula to aid mixing. The reconstituted product should be the consistency of a putty.
Mold the reconstituted product into a cylindrical shape in preparation for implantation.
Use OP-1 PUTTY promptly following reconstitution.
The same procedure should be used to prepare OP-1 PUTTY for the contralateral side of the spine.
Preparation of surgical site:
Step 1: Patient Positioning
Place patient in prone position using an appropriate spine table that allows maintenance of normal spine lordosis.
Step 2: Exposure and Bone Preparation
Make a single midline incision in both the skin and the lumbodorsal fascia.
Strip the paraspinal muscles subperiosteally and retract laterally. Denude the facet joints and transverse processes of all soft tissue.
Step 3: Decortcation
Decorticate all cortical surfaces, including:
The dorsal, lateral, superior, and inferior surfaces of the transverse processes
The dorsal and lateral aspects of the pars interarticularis from the most proximal vertebra, to the most distal vertebra to be included in the fusion.
It is recommended to pack off the lateral gutters with sponges, preferably soaked with epinephrine, to promote hemostasis.
Step 4: Decompression (if necessary)
Perform a decompression of the stenotic portions of the posterior spine.
The decompression may involve a whole or partial laminectomy and may include one or more levels.
Step 5: Inserting Instrumentation (pedicle screws)*, if necessary
Using the preferred surgical technique, insert pedicle screws carefully. (Pedicle screws can be inserted before decompression).
If possible the fixation should also be added at this time. If it is determined that the fixation interferes with the ability to place the OP-1 PUTTY, the fixation should be placed after implantation of the OP-1 PUTTY.
*Decompression may be performed after decortication or after insertion of instrumentation.
Step 6: Placement of OP-1 PUTTY
CAUTION: Surgical manipulations, irrigations or suction to the site should be completed prior to device implantation.
Remove packed sponges.
Provide adequate hemostasis to ensure the OP-1 PUTTY stays at the surgical site. Irrigate the surgical site as necessary prior to implanting the OP-1 PUTTY.
Place the reconstituted OP-1 PUTTY in the decorticated lateral gutters, bridging the dorsal surfaces of the transverse processes.
Ensure that the OP-1 PUTTY directly contacts viable tissue.
One unit of OP-1 PUTTY should be used per side.
Step 7: Closing
Close the soft tissues around the OP-1 PUTTY immediately after implantation. Closure is critical for containment and maintenance of OP-1 PUTTY.
Do not place a drain at the fusion; a drain may only be used subcutaneously if possible.
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 PUTTY is authorized by Federal law for the repair of symptomatic, posterolateral (intertransverse) lumbar spine pseudoarthrosis in patients for whom autologous bone and/or bone marrow harvest are not feasible or are not expected to promote fusion and who have at least one of the following compromising factors: osteoporosis, diabetes or nicotine use. The effectiveness of OP-1 PUTTY for this use has not been demonstrated.
Brief summary of indications, contraindications and warnings:
OP-1 PUTTY is indicated for the repair of symptomatic, posterolateral (intertransverse) lumbar spine pseudoarthrosis in patients for whom autologous bone and/or bone marrow harvest are not feasible or are not expected to promote fusion and who have at least one of the following compromising factors: osteoporosis, diabetes or nicotine use.
OP-1 PUTTY 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 PUTTY may result in (1) the formation of localized ectopic or heterotopic bone outside of the treatment site (2) development of an immune response against BMP-7 or Type I collagen.
There are no adequate well controlled studies of OP-1 PUTTY 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.