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Device indicated for use in hip and shoulder labral repair.
British orthopedic technology company Smith & Nephew plc has released its Suturefix Ultra soft suture anchor, which is indicated for use in both hip and shoulder labral repair. This new anchor’s smaller size and soft construct is designed to allow surgeons to fine tune their repairs by adding additional anchors and fixation points. The U.S. Food and Drug Administration cleared the device in 2013. According to the company, the new soft anchor delivers high fixation strength. Once deployed, its fixation is not dependent on bone quality for security. Its reliable deployment comes from the handle design and safety button which provides surgeons an audible “click” when the anchor is deployed successfully. It features a1.7 mm x 20 mm twist drill, designed to remove less bone than traditional fixation anchors. “The Suturefix Ultra anchor truly is the next generation of hip labral repair fixation; with a reliable deployment that ‘clicks’ to confirm the anchor is set,” said Marc J. Philippon, M.D., of the Steadman Philippon Research Institute. “This anchor system is so versatile I can place it anywhere along the acetabular rim, providing additional fixation points for a secure repair.” Each Suturefix Ultra anchor comes pre-loaded on Ultrabraid high-strength sutures to deliver the security of a strong suture with a low knot stack. The implant is made of Durabraid suture and once implanted, leaves no hard materials behind. “When the design team started working on this anchor, surgeons were very clear with what they wanted; a small, soft anchor that is easy to deploy and delivers excellent fixation in a variety of bone qualities,” said Scott Schaffner, vice president, Global Sports Medicine Franchise for Smith & Nephew. “And as a company known for our sports medicine expertise and pioneering products, we knew that we could deliver.” Pre-clinical testing is based on laboratory research and not clinical testing on actual patients. Therefore, it is not necessarily indicative of actual clinical results. The biomechanical testing was conducted in 15 pounds per cubic feet bone block, a substance with a density equivalent to the worst-case, poorest-quality decorticated humeral bone. The labrum is a type of rigid cartilage found in a ball and socket joint. Attached to the socket, it serves to hold the ball in place and serves as an attachment point for other structures and tissues around the joint. If the labrum is torn away from the bone, a surgeon must reattach it through labral repair. Smith & Nephew continues pioneering hip and shoulder repair with new Suturefix™ Ultra all-suture based soft anchor
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