Healthcare Industry News: Bone Fixation
News Release - October 28, 2014
Dallen Medical Receives FDA Clearance for Tensyn(TM) Band for AC/CC Joint Stabilization
SAN CLEMENTE, Calif.--(Healthcare Sales & Marketing Network)--Dallen Medical Inc., an innovator in Bone Fixation and repair, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tensyn™ Band for acromioclavicular (AC) joint and coracoacromial (CC) ligament repair in shoulder separation. 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 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.
“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.”
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.
About Dallen Medical, Inc.
Dallen Medical is an early-stage orthopedic company whose patented technology provides superior fixation and compression. The Company has eight FDA clearances around its Compressyn™ and Tensyn™ technologies and is targeting underserved markets where it can deliver a higher standard of rigid fixation and compression, where warranted, without compromising speed or ease of use. For more information, visit www.dallenmedical.com.
Source: Dallen Medical
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