Frequent visitor to our pages with its innovative bone fixation and repair devices, Dallen Medical Inc., has gained U.S. FDA 510(k) clearance for its Tensyn™ Band for acromioclavicular (AC) joint and coracoacromial (CC) ligament repair in shoulder separation.
Dallen Medical has eight FDA clearances around its Compressyn™ and Tensyn™ technologies and is targeting what it sees as underserved markets where it can deliver a higher standard of rigid fixation and compression, where warranted, without compromising speed or ease of use.
Designed for orthopedic surgeons, the Tensyn Band technology offers proprietary, knotless banding for stabilized fixation of soft tissue in the shoulder, ankle and other anatomy while allowing physiologically natural movement of those joints not available with rigid screw fixation.
The Tensyn Band is wider than alternatives, distributing fixation pressure across a larger surface area and providing claimed greater ease of use in the surgeon’s hands during the procedure. Other wire-like devices are significantly narrower, concentrating pressure on a very focused area along the bone and potentially risking injury to a surgeon’s hands.
Based on clinical feedback, the company plans to offer the Tensyn Band for AC/ CC joint stabilization in two configurations to allow for a variety of surgical techniques.
The Tensyn Band technology has also been cleared by the FDA for syndesmosis repair.
“This approval marks our eighth FDA clearance as a company and the third within the Tensyn Band family of products,” said Dallen Medical Chief Executive Officer David Mills. “This new device expands the Tensyn Band platform to the upper extremities, providing more options for hospitals and surgery centers treating patients with sports injuries, and positioning the company for product line extensions already in development.”
Source: Dallen Medical, Inc.