PLAINSBORO, N.J., April 17, 2005 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced it has received 510(k) clearance from the United States Food and Drug Administration to market the Suturable DuraGen(TM) Dural Regeneration Matrix in the United States. Suturable DuraGen, the third generation in Integra LifeSciences' line of absorbable onlay collagen matrix grafts for cranial and spinal dural repair, provides the surgeon with the ability to use the graft as either an onlay graft or as a sutured graft.
The dura mater is a tough, fibrous membrane that surrounds and protects the tissues of the brain and spinal cord. Head and spinal injuries often result in laceration of the dura. Some spine or cranial neurosurgical procedures require the dura to be opened or removed to gain access to the delicate tissues contained within. Effective dural closure is necessary to prevent cerebrospinal fluid leaks and allow wound healing to occur. Dural defects may be repaired by several techniques, including commercially available dural graft substitutes. Integra LifeSciences revolutionized closure of the dura mater with the introduction of its onlay absorbable dural grafts, DuraGen(R) and DuraGen Plus(TM). While many neurosurgical procedures benefit from the ability to rapidly close dural defects using an onlay graft, some procedures will greatly benefit from the ability to suture the new graft, Suturable DuraGen.
"Suturable DuraGen Dural Regeneration Matrix leverages Integra's regenerative technology and capitalizes on the unmatched safety and efficacy of the DuraGen family of products. Suturable DuraGen's mechanically enhanced component results in dramatically improved strength allowing for the product to be sutured in place," said Simon Archibald, Ph.D., Integra's Chief Scientific Officer.
"Suturable DuraGen is the only Dural Regeneration Matrix that can be used as an onlay and as a suturable graft whose resorption profile is consistent with the growth of new dural tissue," said Mark Spilker, Director of Regenerative Technologies. The launch of Suturable DuraGen reaffirms Integra's commitment to actively developing and providing innovative solutions for neurosurgical applications that can benefit from Integra's proprietary extra-cellular matrix technologies.
Suturable DuraGen Dural Regeneration Matrix will be sold by the Integra NeuroSciences(TM) sales organization. Integra NeuroSciences is a leading provider of implants, devices, instruments, and systems used in neurosurgery, neuromonitoring, neuro-trauma, and related critical care. Integra NeuroSciences' direct selling effort in the United States and Europe currently involves more than 100 professionals. In all other markets, Integra NeuroSciences products are sold through a network of distributors.
Integra LifeSciences Holdings Corporation is a diversified medical technology company that develops, manufactures, and markets medical devices for use in a variety of applications. The primary applications for our products are neuro-trauma and neurosurgery, reconstructive surgery and general surgery. Integra is a leader in applying the principles of biotechnology to medical devices that improve patients' quality of life. Our corporate headquarters are in Plainsboro, New Jersey, and we have manufacturing and research facilities located throughout the world. We have approximately 1,200 employees. Please visit our website at (http://www.Integra-LS.com).
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the use of our Suturable DuraGen Dural Regeneration Matrix. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of physicians to use Suturable DuraGen Dural Regeneration Matrix may affect the prospects for its use in clinical procedures. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Factors That May Affect Our Future Performance" included in the Business section of Integra's Annual Report on Form 10-K for the year ended December 31, 2004 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.