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Generic Medical Devices Receives FDA 510(K) Clearance for Universal Surgical Mesh

Posted on: Wednesday, 9 May 2007, 09:00 CDT

Generic Medical Devices, Inc.™ (GMD™), the first company to design, develop, manufacture and supply quality surgical products marketed at generic prices, today announced that the U.S. Food and Drug Administration (FDA) has cleared the GMD Universal Surgical Mesh for market. This marks the company's second 510(k) clearance by the FDA for a medical device that will be sold as a generic alternative to existing, standard-of-care surgical products. The availability of the Surgical Mesh will provide hospitals, ambulatory surgical centers, and independent practitioners a low-cost opportunity to administer high-quality healthcare.

"With both domestic and international healthcare systems suffering from rapidly inflating costs, it is becoming increasingly difficult to afford not only cutting-edge care, but also maintain the high volume of common procedures performed daily in hospitals and surgical centers," said Richard Kuntz, president and CEO of Generic Medical Devices. "With the Universal Surgical Mesh, GMD has furthered its goal of providing standard-of-care, efficacious medical devices at dramatically reduced prices. With more than one million hernia operations performed in the United States in the last year alone, the ability to offer healthcare organizations a low-cost surgical mesh for each procedure will create immediate fiscal savings that can be reinvested to provide more patients with needed surgical procedures and support new device innovations."

The GMD Universal Surgical Mesh is a Class II, non-active implantable medical device intended to support tissue growth in open or laparoscopic procedures, which are common for hernia repair. Clearance of the GMD Universal Surgical Mesh is based on the device being substantially equivalent -- having the same or equivalent materials, design specifications, technological characteristics, operation, intended use and performance -- to pre-amendment devices and a product currently on the market.

"This 510(k) clearance demonstrates GMD's advancement in the effort to provide FDA approved generic medical devices to a cost-conscious international healthcare community," added Dr. William Duffell, Jr. Ph.D., Board Member at Generic Medical Devices. "We are excited to continue working with the FDA to introduce new, generic medical devices that meet the highest safety standards while developing devices that ultimately will allow a greater number of patients access to affordable, high-quality and safe healthcare."

The procedure for patients undergoing laparoscopic or open surgical hernia repair involves the implantation of a surgical mesh over the hernia defect to provide a platform for where tissue ingrowth can occur, healing the defect. The GMD Universal Surgical Mesh will be used for this purpose to repair hernia or other fascial defects that require the addition of a reinforcing or bridging material to achieve the desired surgical outcome.

GMD is the first company to implement the generic model, made successful by the pharmaceutical industry, within the medical device market. Leveraging expired patents on standard-of-care surgical devices that have undergone few, if any, changes since first being introduced to the market, GMD is bringing high-quality, substantially equivalent alternatives to market at lower prices. Devices chosen by GMD all have existing 510(k) classification, reimbursement by Medicare and third-party payors, established product safety, efficacy and outcomes, and a trained surgeon/physician base.

About Generic Medical Devices

Generic Medical Devices, Inc.™ is the world's first designer, developer, manufacturer and supplier of quality medical products marketed at generic prices that allow healthcare providers to meet the standard of care for patients. Recognizing the need for healthcare reform and the ever-increasing burden that America's aging population is placing on the healthcare system, GMD™ set out to develop lower-priced products with proven outcomes and "better-than" product features. These generic devices, based on products that are becoming a commodity in the marketplace, allow the healthcare system to provide more patients access to innovative and often expensive treatments while helping to stem the tide of rising healthcare costs. For more information, please visit www.genericmedicaldevices.com.

Safe Harbor Statement

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for certain forward-looking statements. This press release contains forward-looking statements, which reflect our views regarding future events and financial performance. These forward-looking statements are subject to certain risks and uncertainties, including those identified below, which could cause actual results to differ materially from historical results or those anticipated. The words aim, believe, expect, anticipate, intend, estimate and other expressions, which indicate future events and trends, identify forward-looking statements. Actual future results and trends may differ materially from historical results or those anticipated depending upon a variety of factors, including, but not limited to: the effect of government regulation, including when and if we receive approval for marketing products in the United States; the impact of international currency fluctuations on our cash flows and operating results; the impact of technological innovation and competition; acceptance of our products by physicians and patients, our historical reliance on a single product for most of our current sales; our ability to commercialize our recently licensed product lines; our intellectual property and the ability to prevent competitors from infringing our rights; the ability to receive third party reimbursement for our products; the results of clinical trials; our continued losses and the possible need to raise additional capital in the future; our ability to manage our international operations; our ability to hire and retain key technical and sales personnel; our dependence on key suppliers; future changes in applicable accounting rules; and volatility in our stock price. We cannot assure that we can continue our business through new and innovative product introductions.

Source: Business Wire

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