InnerDyne Receives FDA Clearance for INNERVASC Vascular Access Product.Business Editors, Health/Medical Writers SUNNYVALE, Calif.--(BW HealthWire)--June 6, 2000 InnerDyne, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on NM: IDYN) today announced marketing clearance from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for the Company's INNERVASC(R)radially dilatable di·late v. di·lat·ed, di·lat·ing, di·lates v.tr. To make wider or larger; cause to expand. v.intr. 1. To become wider or larger; expand. 2. percutaneous vascular access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing device. In March 2000, InnerDyne granted exclusive U.S. and South American sales and distribution rights to the INNERVASC product for percutaneous vascular access in the fields of cardiology, radiology, neuroradiology neuroradiology /neu·ro·ra·di·ol·o·gy/ (-ra?de-ol´ah-je) radiology of the nervous system. neu·ro·ra·di·ol·o·gy n. 1. The branch of radiology that deals with the nervous system. and critical care to Maxxim Medical, Inc. William G. Mavity, president and chief executive officer of InnerDyne, commented, "With receipt of our 510(k), InnerDyne has now met the conditions of our strategic marketing agreement with Maxxim to allow them to initiate the launch of the product. We look forward to supporting their efforts." It is estimated that more than 6 million percutaneous vascular procedures are performed each year worldwide, including more than 4 million procedures in the U.S. This represents annual market potential for the INNERVASC system in excess of $300 million. Maxxim Medical, Inc. is a major diversified developer, manufacturer and marketer of specialty medical products for use in acute and alternate care settings. InnerDyne, Inc. designs, develops, manufactures and commercializes minimally invasive surgical access products incorporating its proprietary radial dilation dilation /di·la·tion/ (di-la´shun) 1. the act of dilating or stretching. 2. dilatation. di·la·tion n. 1. technology. The Company also is pursuing applications for radial dilation in areas outside its primary market focus, and improvements in its proprietary biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function. coatings technologies, which it intends to commercialize either internally or through strategic alliances. Except for the historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties, including those risks detailed from time to time in the Company's regulatory filings, including the annual report on Form 10-K for the year ended December 31, 1999, and the Forms 10-Q for the quarters ended in 2000, as or to be filed with the Securities and Exchange Commission. |
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