BioMedical Enterprises, Inc. Receives FDA Clearance for Spine Use of Its Memory Metal Implants
Published: Oct 23, 2007
SAN ANTONIO, Oct. 22 /PRNewswire/ -- BioMedical Enterprises, Inc. (BME), a privately held medical device company and leader in orthopedic shape memory implant technology, today announced that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the OSSpine(TM) for use in anterior fixation of the cervical spine to provide enhanced biomechanical stability & bone graft retention. The patent-pending OSSpine(TM) builds on the extremity bone fusion success of BME's OSStaple(TM) and OSSplate(TM), and joins the Step OSStaple(TM) and the OSSArc(TM) dynamic residual compression implants as the most recent additions to BME's OSSforce(TM) Fixation System.
Made of nitinol, a biocompatible alloy possessing shape memory and super-elastic properties, the OSSpine(TM) implant is inserted while in its malleable state at room temperature. Using BME's patent-pending OSSforce(TM) Implant Controller, the implant is safely heated to activate its shape change and impart compression forces across the fusion site. During this process, the implant's legs close and it's s-shaped back shrinks providing uniform compression while the alloy's structure transforms into a state approximately 20% stronger then 316L stainless steel. The OSSpine(TM) implant actively compresses the fusion construct compensating for any graft subsidence that may occur during healing.
BME recently announced that it had received a Notice of Allowance from the United States Patent and Trademark Office for 61 claims providing protection for their innovative OSSforce(TM) Implant Controller technology. The OSSpine(TM) implants and the OSSforce(TM) Implant Controller will be showcased by BME at the North American Spine Society (NASS) 22nd Annual Meeting being held October 23-27, 2007 in Austin, Texas.
BioMedical Enterprises, Inc. (BME) is a medical device company that addresses the changing needs in musculoskeletal medicine. BME focuses on minimally invasive orthopaedic instrumentation and implants that elicit a biologic response. BME's focus on memory metal internal fixation implants is changing the shape of orthopaedic medicine. Its specialized history of musculoskeletal research services will continue to produce unique, state of the art orthopaedic products that provide better outcomes for patients and more convenience to surgeons. For more information visit http://www.bme-tx.com.
CONTACT: Eric Marcano, Marketing Manager of BioMedical Enterprises, Inc.
(BME), 1-800-880-6528, fax, +1-210-677-0355
Web site: http://www.bme-tx.com/