Positive Results Of DuraGen® Dural Graft Matrix Clinical Experience Involving 169 Patients Presented At AANS 2003 Annual Meeting In San Diego
Plainsboro, New Jersey, April 29, 2003-- Integra LifeSciences Holdings Corporation (Nasdaq: IART) today announced that Dr. Peter D. LeRoux of the University of Pennsylvania Neurosurgery and Radiology department presented the results of a prospective study titled "DuraGen® is an effective dural substitute - clinical experience with 169 patients", at the 2003 American Association of Neurological Surgeons Convention in San Diego.
Effective dural closure is necessary to prevent cerebrospinal fluid leaks and for wound healing. During neurosurgical procedures, however, the dura mater may be torn, deficient or removed. These dural defects can be repaired using several techniques, including commercially available dural substitutes. One such substitute, Integra's DuraGen® Dural Graft Matrix, is the only dural substitute that does not require sutures.
Prospective operative data was collected on 169 patients, which included 93 craniotomies, 28 spinal surgeries, 39 posterior fossa operations, and 9 decompressive hemicraniectomies. Wounds were assessed one day, one week and one month later and patients underwent postoperative and three-month neuroimaging studies. This study was undertaken to determine the safety and efficacy of the DuraGen® product.
"In addition to achieving the objective of demonstrating the safety and efficacy of DuraGen®, our study also showed that the use of DuraGen® can reduce procedure time for dural closure and minimize adhesions," said Dr. LeRoux. "DuraGen® is an innovative product that is easy to insert, safe and effective and provides the surgeon with a viable alternative to current dural closure techniques. The results of the study showed that the time to prepare and insert DuraGen® averaged less than five minutes and no significant pseudomeningocele or scar tissue was observed on three month follow-up imaging. In the patients in this study who underwent cranioplasty following decompressive hemicraniectomies, the scalp was easily mobilized and no adhesions or scar formation were observed."
Similar results have been experienced in other institutions in the United States and abroad. The DuraGen® product is now used in over 1,200 hospitals in the United States and has become a standard protocol for repair of cranial as well as spinal dural defects in neurosurgical procedures.
Integra estimates that over 100,000 DuraGen® implants have been used in patients worldwide since the commercial launch of the product in 1999.
The DuraGen® product is sold through the Integra NeuroSciencesT sales organization. Integra NeuroSciences is a leading provider of implants, devices, instruments, and systems used in neurosurgery, neuromonitoring, neurotrauma, 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, plastic and reconstructive surgery, and soft tissue repair. Integra is a leader in applying the principles of biotechnology to medical devices that improve patients' quality of life. The Company has its corporate headquarters in Plainsboro, New Jersey, with manufacturing and research facilities located throughout the world. The Company has approximately 860 permanent employees.
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 future alternative clinical uses of the DuraGen® product. The accuracy of such forward-looking statements is necessarily subject to risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, physicians' willingness to use the DuraGen® product may affect the prospects for its use in additional clinical procedures. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Risk Factors" included in the Business section of Integra's Annual Report on Form 10-K for the year ended December 31, 2002 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
Source: Integra LifeSciences Holdings Corporation
Contact:
Integra LifeSciences Holdings Corporation
John B. Henneman, III
Executive Vice President
Chief Administrative Officer
(609) 936-2481
jhenneman@integra-ls.com