FDA Clears Anika’s X-Twist Knotless Fixation System

Anika Therapeutics, Inc. is expanding its sports medicine soft tissue portfolio, having received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the X-Twist Knotless Fixation System.

The X-Twist Knotless Fixation system is a platform of suture anchors designed to be mechanically strong,¹ easy to use, and support healing for key repairs such as rotator cuff repair. According to SmartTRAK, there were nearly 670,000 rotator cuff procedures performed in 2021, with the majority of these being performed in the ambulatory surgery center (ASC).²
 
“The clearance of the X-Twist Knotless Fixation System is another step forward in establishing Anika as a preferred partner within the ASC,” said Kevin Stone, vice president and general manager, Sports Medicine, at Anika Therapeutics. “Feedback from our surgeon thought leaders has been very positive with a specific focus on the versatility of the anchor and the fixation it provides in both soft and hard bone conditions. Surgeons can use the X-Twist in rotator cuff repair for both medial and lateral row applications, as well as other soft tissue procedures where a knotless anchor is desired. This clearance adds to the family of innovative new products to address high opportunity spaces, such as the shoulder market, that will drive accelerated growth for Anika Sports Medicine and our overall joint preservation portfolio.”
 
The X-Twist Knotless Fixation System affords surgeons a variety of knotless and knotted soft tissue fixation options in a single anchor platform. The design includes venting, intended to support cellular infiltration through the anchor; a double helix thread that allows fast and easy deployment; the ability to support the surgeon’s preferred combination of multiple sliding suture or tape configurations; and the X-Spline drive technology that provides more torque transfer for easy anchor insertion. In addition to the shoulder, X-Twist has direct applications in a variety of procedures, including in the foot and ankle, and will initially be available in PEEK-Optima. 
 
The X-Twist represents the newest innovation within Anika’s Sports Medicine segment focused on the ASC. Combined with Anika’s recent hardware augmentation indication for Tactoset, its proprietary hyaluronic acid-enhanced injectable bone substitute, the X-Twist clearance differentiates Anika among its competition by enabling it to offer a knotless fixation solution for rotator cuff repair in patients with insufficient bone quality.
 
Anika expects to begin commercializing the X-Twist Knotless Fixation System in the second half of 2022 within the United States.

References
¹ Competitive pull-out data on file.
²  SmartTrak 2022
 
PEEK-Optima is a registered trademark of Invibio Limited Corporation.