PLAINSBORO, N.J., Sept. 20, 2002 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that Integra NeuroSciences has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the Selector(R) Integra Ultrasonic Surgical Aspirator for use in general, gynecological, urological, plastic and reconstructive, orthopedic, thoracic and thoracoscopic surgery procedures. The Selector product received FDA 510(k) clearance for the selective removal of soft tissue during neurosurgical and gastroenterology procedures in 1990 and for laparoscopic procedures in 1993.
The Selector product facilitates the removal of cellular and other unwanted soft tissue through ultrasonic vibration and simultaneous irrigation and aspiration. Unlike other surgical techniques, ultrasonic surgery selectively dissects soft tissues, leaving fibrous tissues such as nerves and blood vessels relatively unaffected. It therefore facilitates the ablation of unwanted tissue adjacent or attached to vital structures.
"We are excited to receive FDA clearance for these additional indications," said Stuart M. Essig, Integra's Chief Executive Officer. "These broader indications level the playing field when competing against other ultrasonic aspirators with similar claims. Although the neurosurgeon continues to be our primary call point for the Selector product, the various specialties within the hospital all play a role in the decision to purchase capital equipment such as the Selector system. We believe that these new indications will make it easier for hospitals to choose the Selector product, because it will more completely meet the needs of the various surgical specialties."
Integra NeuroSciences designs, manufactures and sells implants, instruments and monitors used in neurosurgery and intensive care units, primarily for the treatment of neurological trauma and surgery. In the United States, Integra NeuroSciences sells through 63 direct sales territories staffed by personnel called neurospecialists, seven regional managers, and ten clinical development specialists who educate and train both neurospecialists and customers in the use of Integra's products. Integra also sells through a direct sales force in the United Kingdom, France, Germany and Belgium. In the rest of the world, Integra NeuroSciences' products are sold though specialized neurosurgical distributors and dealers.
Integra LifeSciences Holdings Corporation develops, manufactures and markets medical devices, implants and biomaterials primarily used in the treatment of cranial and spinal disorders, soft tissue repair and orthopedics. 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. Integra has approximately 750 permanent employees. Please feel free to visit Integra's 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 Company's expectations for increased market acceptance of the Selector Integra Ultrasonic Surgical Aspirator. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, clinical acceptance of the Selector product outside by medical practitioners outside the neurosurgery department may affect the Company's ability to increase market share for the product. 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, 2001 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.