Arthrex launches FDA-cleared ACL primary repair kit

Dec. 28, 2020

Arthrex announced the launch of the SwiveLock ACL Repair Kit, following clearance by the U.S. Food and Drug Administration (FDA) of the SwiveLock anchor for ACL repair. According to the company, it is the first and only FDA-cleared kit for the primary repair of anterior cruciate ligament (ACL) tears. 

“Arthrex is defining the future for ACL treatment as the first orthopedic company to develop and market a kit specifically for ACL repair,” said President and Founder Reinhold Schmieding. “This is a significant achievement in orthopedic surgery and another testament to Arthrex’s continuous innovation and dedication to its mission of Helping Surgeons Treat Their Patients Better.” 

ACL primary repair with the SwiveLock ACL Repair Kit involves reattaching a torn ACL utilizing SwiveLock anchors and high-strength FiberWire and TigerWire sutures. The repair utilizes an InternalBrace ligament augmentation, which enables patients to return to activity more quickly while protecting the repaired ligament. The kit contains all the surgical products needed for the ACL repair technique. 

Traditional treatment for most ACL tears involves a surgical reconstruction technique, in which graft tissue from the patient’s body or donor tissue is used to recreate the damaged ligament. What a patient receives – reconstruction or repair – is determined by numerous criteria, such as what portion of the ACL is torn, the quality of the remaining ACL tissue, the patient’s goals and activity level, and the acuteness from the initial injury. The kit is indicated for use in proximal ACL tears (tears off the femur), which results in roughly 16 percent of all ACL tears. 

“ACL primary repair offers a fully arthroscopic, more minimally invasive and patient-friendly surgical option for certain types of tears when compared to traditional reconstruction techniques,” said Arthrex Vice President of Strategic Development Larry Higgins, M.D. “Arthrex innovations in technology and techniques have significantly improved outcomes since the origination of this procedure 50 years ago and now provides surgeons the potential to restore a patient’s native anatomy and proprioception. These advancements may allow for a quicker return to activity and diminish pain following the procedure. While primary ‘repair’ will not replace reconstruction for all cases, the procedure, utilizing the SwiveLock ACL Repair Kit, is valuable tool to help surgeons treat their patients better.” 

The first ACL primary repair with the new kit was completed on Nov. 23, 2020 by Gregory DiFelice, M.D, an orthopedic surgeon at The Hospital for Special Surgery in New York who pioneered this technique and developed this kit in partnership with Arthrex. 

“I am very excited about the release of the SwiveLock ACL Repair Kit. I have been performing ACL primary repair using this technique for more than a decade now and we have developed this kit so that surgeons have all the tools necessary to make this procedure seamless,” he said. 

Arthrex has the release