Endosonics receives FDA go-ahead to market new rail-design heart catheters.PLEASANTON, Calif.--(BUSINESS WIRE)--May 23, 1995--Endosonics Corporation (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 :ESON ESON Ethernet Switched Optical Network (Alamedia Networks) ESON Ethnobotanical Society of Nepal ) announced today that the Company's Cardiovascular Dynamics, Inc. (CVD CVD Cardiovascular disease, see there ) subsidiary has received notification from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) of U.S. marketing approval of its Premarket Notification (510k) submission for three catheter models of its Bullett(R) F/X F/X Effects (R) site-specific drug delivery catheters. The Bullett F/X catheters utilize CVD's patented Multiple Microporous Membrane (M3) Technology to provide precise and accurate delivery of therapeutic solutions to remote anatomical locations within the body. CVD's M3 Technology also provides superior flexibility for maximum catheter performance in accessing difficult-to-reach locations in the body's anatomy. This submission included three Bullett F/X rail-design catheter models for coronary (i.e. heart) applications. The company has three issued site-specific drug delivery patents and multiple patents pending on rail-design, site-specific drug delivery catheters. These three different models of Bullett F/X catheters provide different flow rates and dosage regimens of therapeutic agents to be administered in a localized, site-specific manner to treat diseases in different locations within the arteries of the heart. The Bullett F/X will be the first CVD catheters marketed in the U.S. for coronary applications using CVD's proprietary rail catheter design. During the fourth quarter of 1994, the Company received FDA allowance to market six models of Bullett catheters for peripheral vascular applications. Earlier this month, CVD announced 510k approval of its first coronary catheters, the Bullett(R) Hi-Flo over-the-wire-catheters. The company plans limited distribution of both the Bullett Hi-Flo and Bullett F/X catheters in the third quarter, with full market release by the end of 1995. Commenting on this approval, Endosonics Chairman Michael Henson Michael Henson is a Cincinnati based teacher, activist and writer. Born April 14, 1947 in Sidney, Ohio he moved to Cincinnati to attend Xavier University where he majored in English. He later received a masters in English from University of Chicago. said, "The U.S. Market release of the Bullett F/X products for coronary use is another step forward for CVD product technology. The launch of these products will enable us to broaden the use of this technology to those cardiologists who prefer rail-design coronary catheters, expanding the total market potential for Bullett products." Endosonics develops and markets intravascular ultrasound Intravascular ultrasound (IVUS) is a medical imaging methodology using a specially designed catheter with a miniaturized ultrasound probe attached to the distal end the catheter. The proximal end of the catheter is attached to computerized ultrasound equipment. imaging systems and catheters. CVD develops and markets site-specific drug delivery and advanced therapeutic catheters. CONTACT: Endosonics Corporation Michael Henson, 714/457-9546 |
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