MINNEAPOLIS, Minn. — Minnesota Medical Development, Inc. (MMDI) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its new Rebound HRD(TM) (Hernia Repair Device). The Rebound HRD is intended to assist in the repair and/or reinforcement of hernia or other soft tissue defects where weakness exists and where the support of a nonabsorbable material is preferred.
MMDI also recently received ISO 13485:2003 (Quality Management) and Directive 93/42/EEC (CE Mark) certifications for the design, manufacture and distribution of its Rebound HRD(TM) in European Union member countries.
The Rebound HRD(TM) is a self-expanding Nitinol framed/surgical mesh medical device designed for the laparoscopic repair of both inguinal and ventral hernias. The super-elastic Nitinol frame allows the device to be folded and inserted laparoscopically. Once deployed, the device fully unfurls or “rebounds” back to its original shape – ready for quick and easy placement over the hernia defect.
The Rebound HRD(TM) conforms to the anatomy while providing stability; eliminating the need for anchoring, which in turn, minimizes patient post-op discomfort and the risk of nerve/blood vessel injury. Although the Rebound HRD(TM) is ideally suited for laparoscopic surgery it may also be placed via an open incisional approach.
“The FDA’s 510(k) clearance of the Rebound HRD(TM) serves as recognition for the efforts of many who contributed to the planning, product development and testing of the device and its manufacture. Its basic design lends itself to being manufactured in many shapes, sizes and configurations — the possibilities are limitless and we are already in the process of developing additional models to accommodate a wider variety of soft tissue repairs,” said MMDI Chief Marketing Officer, Steve Nuss. “In the United States alone, over 800,000 inguinal and ventral hernias are repaired annually using surgical meshes. Industry experts are predicting steady growth in that number as the baby boomer generation continues to age and the incidence of obesity increases,” he added.
In 2006, The Society of Laparoendoscopic Surgeons (SLS) recognized the Rebound HRD(TM) as one of the “2006 Innovations of the Year.” The SLS acknowledged the Rebound HRD(TM) as part of its 15th International Congress and Endo Expo 2006, held September 6-9 in Boston, Massachusetts.
Additional information can be obtained at: http://www.2mdinc.com
The SLS does not endorse or approve any products.
About MMDI
MMDI was established in 2001 and is based in Plymouth, Minnesota. Located in the heart of Minnesota’s “Medical Alley,” MMDI has access to some of the world’s finest medical product development, manufacturing and marketing resources. The Company’s primary objective is to identify, develop, patent and manufacture unique medical devices that provide significant clinical benefits and market opportunities.
[tags]MMDI Rebound HRD, Hernia Repair Device, Minnesota Medical Development Inc, FDA 510k clearance[/tags]
