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Home » Arthrex wins FDA clearance for TightRope implant for pediatric ACL surgery

Arthrex wins FDA clearance for TightRope implant for pediatric ACL surgery

January 10, 2023 By Sean Whooley

Arthrex TightRope ACL implant pediatric
[Image courtesy of Arthrex]
Arthrex announced today that it received FDA clearance for pediatric indications for its anterior cruciate ligament (ACL) TightRope implant.

Naples, Florida-based Arthrex designed TightRope for the surgical treatment of orthopedic injuries. According to a news release, it’s the first and only fixation device for ACL injuries cleared for pediatric use.

Arthrex offers a portfolio of ACL TightRope fixation devices. It includes the ACL TightRope II implant and the TightRope attachable button system (ABS) and implant. It also features the FiberTag TightRope implant and the ACL Repair TightRope implant with FiberRing sutures.

The company worked with orthopedic surgeons from the Hospital for Special Surgery (HSS). It developed techniques and instrumentation for ACL surgery with Dr. Frank Cordasco and Dr. Daniel Green of HSS. These include guides for addressing a growing population of young athletes facing ACL injuries.

“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,” said Arthrex President and founder Reinhold Schmieding. “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.”

About Arthrex’s efforts in treating pediatric ACL injuries

Arthrex and HSS developed an all-epiphyseal technique for skeletally immature patients. It involves avoiding the pediatric growth plates to repair or reconstruct the ACL. Patient-specific instrumentation helps surgeons drill sockets for the new, reconstructed ACL. In doing so, they avoid the growth plate, reducing the potential for growth disturbance.

“The expansion of Arthrex’s knee ligament portfolio to include pediatric- and young-adolescent-specific instrumentation and implants, along with the new indications cleared by the FDA, represents a substantial improvement on existing treatment options in this high-risk population of athletes,” said Dr. Cordasco.

Older, adolescent patients approaching skeletal maturation require drilling across growth plates. The surgeons in these cases use an all-soft-tissue autograft.

“These pediatric- and young-adolescent-specific guides help surgeons address the young athlete’s unique anatomy, greatly enhancing surgical options for reconstruction and epiphyseal fixation for ligamentous reconstruction or avulsion injury repair,” said Dr. Green.

Filed Under: Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance Tagged With: arthrex, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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