New FDA 510(k) Clearance Expands Anika's Sports Medicine Soft Tissue Portfolio
Anika Therapeutics Inc (NASDAQ: ANIK) has received FDA 510(k) clearance for the X-Twist Knotless Fixation System, a platform of suture anchors designed to be mechanically robust, easy to use, and support healing for critical repairs such as rotator cuff repair.
According to SmartTRAK, nearly 670,000 rotator cuff procedures were performed in 2021, mainly in the ambulatory surgery center.
"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.
The design includes venting, intended to support cellular infiltration through the anchor, a double helix thread allowing fast & easy deployment, supports the surgeon's preferred combination of multiple sliding sutures or tape configurations, and X-Spline drive technology for more torque transfer for easy anchor insertion.
In addition to the shoulder, X-Twist has direct applications in various procedures, including the foot and ankle, and will initially be available in PEEK-Optima.
Anika expects to begin commercializing the X-Twist Knotless Fixation System in the second half of 2022 in the U.S.
Price Action: ANIK shares are down 3.93% at $21.03 during the market session on the last check Friday.
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