SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Dallen Medical announced today that it has received FDA 510(k) clearance for a polymer coated Compressyn™ Band for sternal closure. This clearance follows the 510(k) FDA clearances that Dallen has received the past 18 months for a non-coated Compressyn Band and the company’s Compressyn Staple for foot, ankle & hand fixation and repair.
According to David Mills, President and CEO of Dallen Medical, “This clearance reflects Dallen’s response from physicians and marks the expansion of the Compressyn product line. The Compressyn Band offers the best combination of fixation-with-compression at an attractive value to hospitals. Equally important, our coated version provides the company with future opportunities to penetrate the sternal closure market which, in the U.S. alone, represents over 445,000 procedures annually.”
Al Memmolo, COO, added, “As a permanent implant, the coated Compressyn Band opens the door to offering this polymer coating to future banding technologies.”
Dallen Medical’s innovative Compressyn and Tensyn™ technology provides clinicians with next-generation fixation-with-compression solutions for use in sternal closure, small bone, and sports medicine procedures.”
About Dallen Medical
Dallen Medical is dedicated to the development of optimized bone fixation and repair technologies and devices. The company’s mission is to provide significant improvements in rigid fixation-with-compression solutions over current devices. Equally significant, all of the company’s developmental efforts, technologies, and products adhere to the AO Foundation’s Principles of Orthopedics. The overriding intent of all of Dallen Medical’s innovative, cost-effective devices is to facilitate improved patient outcomes and shorter hospital stays—resulting in meaningful clinical benefits for patients, physicians and hospitals, worldwide.
