FDA clears first ACL reconstruction device for use in paediatric patients

pharmafile | January 11, 2023 | News story | Medical Communications  

The FDA has cleared the ACL TightRope® II implant to treat torn knee ligaments in children and adolescents. The implant was developed with the aim of addressing a so-called ‘epidemic’ of knee injuries in young athletes who are at higher risk of anterior cruciate ligament (ACL) injuries.

The device was initially based on a similar device designed for use in adult patients but has been adapted to accommodate the growing skeleton of younger athletes. This therefore means that surgeons can use less invasive techniques to minimise any damage to the growth plates while reconstructing the ligament.

ACL tears have becoming increasingly common in paediatric patients recently, in part due to children taking part in sports. Surgeons have often been reluctant to operate on children due to the growth plates in their legs not being entirely fused yet, and operating on underdeveloped bones can lead to permanent deformities to the legs, so this new technology is a huge step forward in treating paediatric patients with this type of injury.

Dr Frank A. Cordasco, MD, MS, sports medicine surgeon at Hospital for Special Surgery (HSS), New York, US, commented: “Our research has demonstrated that more than 90% of children who have undergone the surgery with this implant at HSS have returned successfully to sports without the need for additional surgery.”

Dr Green, MD, MS, FAAP, FACS, added: “The ideal patient for the procedure is, in general, a child between the ages of 12 and 15 to 16, depending on the athlete’s skeletal maturity, at which point the growth plates are effectively closed.”


Betsy Goodfellow

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