NORWOOD, MA –- DePuy Mitek, Inc., a manufacturer of surgical sports medicine devices, announced today the launch of the BIO-INTRAFIX™ Soft Tissue Tibial Fixation System. BIO-INTRAFIX™ is the next-generation of soft tissue tibial fixation for Anterior Cruciate Ligament (ACL) repair, combining the proven success of the INTRAFIX™ System, DePuy Mitek's leading ACL repair product for over five years, with the bioabsorbable BIOCRYL™ material, comprised of osteoconductive TCP and bioabsorbable PLA.
BIO-INTRAFIX™ was developed to address the growing trend in the use of soft tissue grafts in ACL repair procedures (replacing the torn ACL with a hamstring tendon graft harvested from the patient) as an alternative to the widely used bone-tendon-bone patella tendon repair.
"In 1998, 20-30 percent of the ACL repair procedures I performed were done using soft tissue tibial fixation. Today that number has increased to 80 percent," said John C. Richmond, M.D., chairman of Orthopedics at New England Baptist Hospital in Boston, MA. "This increase is due in part to the benefits provided by the soft tissue procedure, over the bone-tendon-bone procedure, including smaller incisions resulting in smaller scars, the potential for a shorter rehabilitation time, as well as less kneeling pain."
The new BIO-INTRAFIX™ System was created based on DePuy Mitek's INTRAFIX™ System. The BIO-INTRAFIX™ System consists of two bioabsorbable (TCP/PLA) components: the expansion sheath and the tapered screw; both molded from BIOCRYL™ material, a composite of PLA and osteoconductive TCP (Tricalcium Phosphate).* Both systems achieve fixation by placing the expansion sheath into the tibial tunnel between the soft tissue graft strands and then inserting the screw into the sheath. The system compresses the graft against the tunnel and, due to the design of the expansion screw, engages the cortical wall at the distal end of the tunnel creating strong, rigid fixation. In one study, the BIO-INTRAFIX™ System produced pullout strength of 1067N (the amount of force it would take for a screw to pull out of bone), equivalent to/better than bone-tendon-bone results.*
BIO-INTRAFIX™ is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction. The BIO-INTRAFIX™ screw is available in three sizes: 6-8 x 30 mm, 7-9 x 30 mm and 8-10 x 30 mm.
Source: Johnson & Johnson