Arthrex Receives FDA Clearance for the TightRope® Implant as First Device Cleared Only for Pediatric ACL Surgery

“For more than a decade, Arthrex has worked closely with leading HSS orthopedic surgeons to develop minimally invasive solutions for ACL surgery for children and young adolescents,” said Arthrex President and Founder. Reinhold Schmieding. “We are proud to partner with surgeons from the Hospital for Special Surgery to tailor treatment options specifically for ACL injuries in younger patients. This is an important achievement in orthopedics and another testament to Arthrex’s dedication to its mission of helping surgeons treat their patients better™,” Starting from an early age.”

Dr.. Cordasco and Green Arthrex helped develop pediatric and teen-specific device guides to address the growing number of young athletes facing ACL injuries.

“The expansion of Arthrex’s knee ligament portfolio to include devices and implants for children, youth, and adolescents, along with new indications approved by the FDA, represents a significant improvement over existing treatment options in this population of high-risk athletes,” said Dr. Cordasco.

While ACL injuries are most common in patients between the ages of 10 and 29 years, earlier treatment options for the younger end of these patients have centered on adapting surgical techniques and devices initially developed for adults. The Arthrex all-epiphyseal technique was developed for skeletally immature patients and involves avoiding pediatric growth plates to repair or reconstruct the anterior cruciate ligament. Using pediatric device guides, surgeons drill sockets for the new, reconstructed ACL by avoiding the growth plate to reduce the possibility of a developmental disruption.

In older adolescent patients who are approaching skeletal maturity, surgeons will drill through growth plates to reconstruct the ACL using a soft tissue autograft. Of the two soft tissue autografts available for use in these young athletes, quadriceps muscle autografts were found to produce better results compared to hamstring autografts with lower revision rates and greater rates of return to sports.2

“This pediatric, youth, and adolescent evidence helps surgeons address the unique anatomy of the young athlete, greatly enhancing surgical options for epiphyseal reconstruction and stabilization to reconstruct ligaments or repair an avulsion injury,” said Dr. Green.

ACL injuries are among the most common sports injuries, with more than 200,000 occurring each year.3 Injuries occur mostly in young and active athletes and are usually caused by non-contact sprains or hyperextension injuries but can also occur due to contact injuries.

The Arthrex ACL TightRope family of fixation devices includes the ACL TightRope II implant, TightRope Attachable Button System (ABS) and implant, FiberTag® TightRope implant, and ACL Repair TightRope implant with FiberRing™ sutures.

For more information, visit https://www.arthrex.com/knee/acl-tightrope-ii-implant.

About Arthrex

Arthrex Inc. , headquartered in Naples, FloridaInc., is a global leader in multidisciplinary, minimally invasive surgical technologies, medical research, manufacturing and medical education. Arthrex develops and releases more than 1,000 new products and procedures each year to drive innovation in orthopedics, trauma, spine, and arthroplasty worldwide and specializes in cutting-edge technologies. 4k Multidisciplinary surgical visualization and integration technology solutions in the operating room. For more information, visit www.arthrex.com.

References

  1. US News & World Report. Best orthopedic hospitals. has been accessed November 30, 2022. https://health.usnews.com/best-hospitals/rankings/orthopedics
  2. Cordasco FA, Black SR, Price M, et al. Return to sport and reinstatement rates in patients <20 years of age after primary anterior cruciate ligament reconstruction: risk profile to compare 3 groups of patients based on skeletal age. I J Sports Med. 2019; 47 (3): 628-639. doi: 10.1177/0363546518819217
  3. Sherman C, Calce J, Ray T, et al. The ACL Study Group Presents Global Trends in Anterior Cruciate Ligament Reconstruction: A Biennial Survey of the ACL Study Group. issakos. 2021; 6 (6): 322-328. doi: 10.1136/jisakos-2020-000567

Source: Arthrex, Inc.

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