Medical device firm Arthrex has secured clearance from the US Food and Drug Administration (FDA) for its ACL TightRope implant for paediatric anterior cruciate ligament (ACL) indications.
The TightRope implant is claimed as the only fixation device for ACL injuries that have been approved for use in children for orthopaedic injuries.
Arthrex president and founder Reinhold Schmieding said: “For more than a decade, Arthrex has worked closely with leading orthopedic surgeons from HSS to develop minimally invasive solutions for pediatric and young adolescent ACL surgery.
“We are proud to partner with surgeons from the Hospital for Special Surgery to design treatment options specifically for ACL injuries in younger patients.
“This is a significant achievement in orthopedic surgery and another testament to Arthrex’s dedication to its mission of Helping Surgeons Treat Their Patients Better, starting from an early age.”
Additionally, the firm has developed all-epiphyseal and transphyseal techniques and instrumentation for ACL surgery.
When repairing or reconstructing the ACL, the Arthrex all-epiphyseal approach avoids the paediatric growth plates and was created for patients with skeletal immaturity, Arthrex said.
In order to reduce the possibility of growth disruption, surgeons drill sockets for the new, rebuilt ACL while avoiding the growth plate using paediatric-specific equipment guidance.
According to the firm, surgeons will drill across the growth plates in older adolescent patients who are nearing skeletal maturation in order to repair the ACL using an all-soft-tissue autograft.
In comparison to hamstring autografts, quadriceps autografts are said to produce better results in the young athlete population, with lower revision rates and higher rates of return to sport, the medical device firm added.
The ACL TightRope II implant, the TightRope attachable button system (ABS) and implant, the FiberTag TightRope implant, and the ACL Repair TightRope implant with FiberRing sutures are all part of the Arthrex ACL TightRope fixation device portfolio.
