Francesco Cordasco

FDA Provides Clearance of First-Ever Device for ACL Reconstruction in Children

Retrieved on: 
Tuesday, January 10, 2023

NEW YORK, Jan. 10, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has provided clearance for use of the ACL TightRope® II implant as the first-ever device for reconstructing torn knee ligaments in children and adolescents. The technology is based on a related device commonly used in adults undergoing anterior cruciate ligament (ACL) reconstruction, but with features specifically designed to accommodate the growing skeletons of young athletes. The key advantage of the new technique is that it allows surgeons to tension the graft sequentially to ensure proper fixation and strength and to utilize minimally invasive techniques to diminish damage to the growth plates while performing a successful reconstruction.

Key Points: 
  • The technology is based on a related device commonly used in adults undergoing anterior cruciate ligament (ACL) reconstruction, but with features specifically designed to accommodate the growing skeletons of young athletes.
  • Cordasco and Green also developed pediatric- and young-adolescent-specific instrumentation guides to address an increasing population of injured high-risk young athletes.
  • Until relatively recently, however, surgeons were reluctant to operate on children whose growth plates in the legs had not fused.
  • MRI Signal Intensity of Quadriceps Tendon Autograft and Hamstring Tendon Autograft 1 Year After Anterior Cruciate Ligament Reconstruction in Adolescent Athletes.

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

Retrieved on: 
Tuesday, January 10, 2023

NAPLES, Fla., Jan. 10, 2023 /PRNewswire/ -- Arthrex, a global leader in minimally invasive surgical technology, announced today its ACL TightRope implant has received clearance from the U.S. Food and Drug Administration (FDA) for pediatric indications. The TightRope implant is used in the surgical treatment of orthopedic injuries and is the first and only fixation device for anterior cruciate ligament (ACL) injuries cleared for pediatric use.

Key Points: 
  • The TightRope implant is used in the surgical treatment of orthopedic injuries and is the first and only fixation device for anterior cruciate ligament (ACL) injuries cleared for pediatric use.
  • Cordasco and Green helped Arthrex develop pediatric and young adolescent-specific instrumentation guides to address a growing population of young athletes facing ACL injuries.
  • The Arthrex all-epiphyseal technique was developed for skeletally immature patients and involves avoiding the pediatric growth plates to repair or reconstruct the ACL.
  • The Arthrex ACL TightRope portfolio of fixation devices includes 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.