Virtuoso Smart CPAP system Cleared by the FDA
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Virtuoso Smart CPAP system Cleared by the FDA

MURRYSVILLE, Pa, Oct. 2, 1996 -- Respironics Inc. (NASDAQ/NMS Symbol: RESP) announced Wednesday that it has been granted clearance by the United States Food and Drug Administration to market its new, automatically adjusting Virtuoso(TM) Smart Continuous Positive Airway Pressure (CPAP) system for the treatment of Obstructive Sleep Apnea.

The company also received notice that the product's (smart) technology has been granted patent protection by The United States Patent and Trademark Office.

"In pursuing this important coverage, we cited related patents awarded to various competitors and were granted protection over their claims," reported Robert D. Crouch, vice president sales and marketing. The patent issued July 30, Crouch said.

Introduced in European markets during fiscal year 1996's second quarter, the new unit continuously tracks the patient's airway condition to meet fluctuating pressure needs, Crouch explained.

"We believe Virtuoso will take CPAP treatment of OSA to a new level, and the patient benefits generated by its highly customized design underscores our continuing leadership in the development of therapy delivery devices," he added.

Virtuoso is the most sophisticated of Respironics' new line of Great Performers(TM) series of therapeutic OSA products. Aria(TM), a companion unit, and Maestro(TM), a patient data monitoring and system control device used in the prescribing of airway pressure, both received 510(k) clearance from the FDA during 1996 after initial availability in Europe.

Respironics Inc. designs, develops, manufactures and sells respiratory medical products for use in the home, hospitals, and in emergency care situations. Late in January, the company announced that it has been awarded ISO 9001 certification from the International Organization of Standardization, a Geneva, Switzerland-based quality standards organization.

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