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NEWS ARCHIVES : U.S. and World News :
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Press Release:
MMDI's Rebound HRD(TM) Receives FDA 510(k) Clearance
 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 by contacting Steve Nuss, Chief Marketing Officer at 763-354-7105 or snuss@2mdinc(.com). You may also visit our website at: 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.
NEWS SOURCE: Minnesota Medical Development, Inc.
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Minnesota Medical Development, Inc. : » MMDI Announces Agreement with Novation to Supply the Rebound HRD » MMDI's Rebound HRD V Receives FDA 510(k) Clearance » USPTO Issues a Notice of Allowance for MMDI's BetaWire(TM) Guidewire Patent
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REFERENCES: MMDI's Rebound HRD(TM) Receives FDA 510(k) Clearance, Rebound HRD, FDA 510k Clearance, Minnesota Medical Development Inc, Hernia Repair Device, self-expanding Nitinol framed/surgical mesh medical device designed for the laparoscopic repair of both inguinal and ventral hernias, medical product development, manufacturing and marketing resources, ISO 13485:2003, press release, Aug 21, 2007. |
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