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FDA clears Arthrex TightRope implant for pediatric ACL injuries

Arthrex’s TightRope implant for treating pediatric anterior cruciate ligament (ACL) injuries has received clearance from the US Food and Drug Administration.

The US Food and Drug Administration has given clearance to Arthrex’s TightRope implant for treating anterior cruciate ligament (ACL) injuries in pediatric patients.

Arthrex has partnered with Frank A. Cordasco, MD, MS; and Daniel W. Green, MD, MS, FAAP, FACS, orthopedic surgeons from the Hospital for Special Surgery, the top ranked hospital in the United States. 

According to Reinhold Schmieding, president and founder of Arthrex, this partnership has led to the development of minimally invasive solutions for treating ACL injuries in children and adolescents. These solutions help to address the rising prevalence of ACL injuries in young athletes.

ACL injuries are most often seen in individuals aged 10 to 29 years, but surgical techniques and devices for treatment have been developed for adults, then adapted for a younger population. The technique developed by Arthrex focuses on reconstructing the ACL while avoiding pediatric growth plates, making it suited for skeletons which have not fully matured.

In younger patients, Arthrex’s technique reduces the risk of growth disturbance by avoiding pediatric growth plates. In older adolescents, surgeons use an all-soft-tissue autograft and drill across the growth plates. Evidence has shown improved outcomes such as lower revision rates and greater return-to-sport rates in quadriceps autografts compared to hamstring autografts.

More than 200,000 ACL injuries occur annually, making it one of the most common injuries in sports. Non-contact twisting or hyperextension injuries are the most common cause of ACL injuries but contact injuries can also lead to ACL injuries. ACL injuries are most often seen in young and sports-active populations.

Arthrex’s ACL TightRope portfolio includes the ACL TightRope II implant, the TightRope attachable button system and implant, the FiberTagTightRope implant, and the ACL Repair TightRope implant with FiberRing sutures.

Reference

Arthrex receives FDA clearance for TightRopeimplant as first, only device cleared for pediatric ACL surgery. Arthrex Inc. January 10, 2023. Accessed January 12, 2023. https://www.prnewswire.com/news-releases/arthrex-receives-fda-clearance-for-tightrope-implant-as-first-only-device-cleared-for-pediatric-acl-surgery-301717178.html