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Anika Receives FDA 510(k) Clearance for the X-Twist™ Knotless Fixation System, Expanding its Sports Medicine Soft Tissue Portfolio
X-Twist provides a simple, versatile knotless suture anchor system ideal for key repairs in the shoulder, foot and ankle, and other extremities BEDFORD,
About this update from Anika Therapeutics Inc.
[{"type":"text","content":"X-Twist provides a simple, versatile knotless suture anchor system ideal for key repairs in the shoulder, foot and ankle, and other extremities\nBEDFORD, Mass., May 20, 2022 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company focused on early intervention orthopedics, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the X-TwistTM Knotless Fixation System. The X-Twist Knotless Fixation system is a platform of suture anchors designed to be mechanically strong1, 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. “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 feature-rich 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 unique X-Spline™ drive technology which 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 innovatio...