NORWOOD, Mass., June 24 /PRNewswire/ -- DePuy Mitek, Inc., a leading
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(TM) 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, which has a successful history of clinical use since 1999. 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
"I have been very impressed with BIO-INTRAFIX and I will continue using it
for my soft tissue tibial fixation procedures," said Dr. Joseph H. Sklar,
M.D., from New England Orthopedic Surgeons in Springfield, MA.
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 30mm, 7-9 x 30mm and 8-10 x 30mm. Additional information
on BIO-INTRAFIX and the BIOCRYL material is available at http://www.mitek.com.
* Data on File.
About DePuy Mitek, Inc.
DePuy Mitek, Inc., a Johnson & Johnson company, is a leading developer and
manufacturer of surgical sports medicine and soft tissue repair devices. The
company's product lines offer a vast array of surgical solutions to assist in
addressing the challenges of soft tissue repair in the shoulder and knee.
DePuy Mitek's suture-anchoring implants are recognized worldwide as the gold
standard for tissue repair in a wide range of clinical indications. By
providing Materials, Instruments and Techniques, DePuy Mitek drives Results
for its customers. DePuy Mitek is now part of the DePuy, Inc. franchise,
which includes DePuy Orthopaedics, DePuy Spine and DePuy Trauma. For more
information, visit http://www.mitek.com.
SOURCE DePuy Mitek, Inc.