Arthrex Launches First FDA-Cleared ACL Primary Repair Kit

NAPLES, Fla., Dec. 18, 2020 /PRNewswire/ — Arthrex, a global leader in minimally invasive orthopedic technology, announced today the launch of the SwiveLock® ACL Repair Kit, following clearance by the U.S. Food and Drug Administration of the SwiveLock® anchor for ACL repair. 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 with the first FDA-cleared kit for the primary repair of 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 quickly¹ while protecting the repaired ligament. The kit is convenient and 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 tears².

“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 November 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 been involved in developing the ACL primary repair procedure since 1983 with the goal of helping patients maintain their native tissue while returning to activity more quickly. In developing this technique and kit, the company has thoroughly studied the procedure and associated patient outcomes in peer reviewed literature^3,4,5,6 as well as Arthrex’s Surgical Outcomes System™ (SOS), an orthopedic and sports medicine global registry that tracks patient outcomes following common orthopedic and sports medicine medical procedures across the U.S.

For more information about the SwiveLock® ACL Repair Kit: https://engage.arthrex.com/Media-Kit-ACL-Repair-Kit  

About Arthrex
Arthrex Inc., headquartered in Naples, FL, is a global leader in orthopedic surgical device design, research, manufacturing and medical education. Arthrex develops and releases more than 2,000 new products and procedures every year to advance minimally invasive orthopedics worldwide. For more information, visit www.Arthrex.com or www.OrthoPedia.com.

References

1. van der List JP, DiFelice GS. Arthroscopic primary anterior cruciate ligament repair with suture augmentation. Arthrosc Tech. 2017;6(5):e1529-e1534. doi:10.1016/j.eats.2017.06.009
2. The location of anterior cruciate ligament tears: a prevalence study using magnetic resonance imaging. Orthop J Sports Med. 2017;5(6):2325967117709966. doi:10.1177/2325967117709966
3. Clinical outcomes of arthroscopic primary anterior cruciate ligament repair: a systematic review from the scientific anterior cruciate ligament network international study group. Arthroscopy. 2020;36(2):594-612. doi:10.1016/j.arthro.2019.09.021
4. Arthroscopic primary repair of proximal anterior cruciate ligament tears seems safe but higher level of evidence is needed: a systematic review and meta-analysis of recent literature. Knee Surg Sports Traumatol Arthrosc. 2020;28(6):1946-1957. doi:10.1007/ s00167-019-05697-8
5. Patients forget about their operated knee more following arthroscopic primary repair of the anterior cruciate ligament than following reconstruction. Arthroscopy. 2020;36(3):797-804. doi:10.1016/j.arthro.2019.09.041
6. Anterior cruciate ligament repair with suture augmentation for proximal avulsion injuries. Arthrosc Sports Med Rehabil. 2020;2(5):e475-e480. doi:10.1016/j.asmr.2020.05.003