CardioVascular Dynamics To Launch Three New Products At TCT Meeting.IRVINE, Calif.--(BW HealthWire)--Sept. 17, 1997--CardioVascular Dynamics 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 :CCVD CCVD Communauté de Communes du Val de Drôme CCVD Combustion Chemical Vapor Deposition ) Wednesday announced that it will introduce three new product lines at the international TransCatheter Therapeutics (TCT TCT The Capital Times (Madison, WI newspaper) TCT Transcatheter Cardiovascular Therapeutics TCT The Coroner's Toolkit TCT Trans Canada Trail TCT Tcl Core Team TCT Tsukuba College of Technology (Japan) ) meeting to be held during the week of Sept. 22-27, 1997. The three new product lines to be launched at the TCT meeting are: Lynx OTW OTW Otherwise OTW Off The Wall OTW On the Way OTW On the Whole OTW Of The World (online TV network) OTW On The Web OTW Out the Window (display/graphics) OTW On The Water Catheters The Lynx Over-the-Wire PTCA PTCA abbr. percutaneous transluminal coronary angioplasty PTCA Percutaneous transluminal coronary angioplasty, see there Catheters will be introduced on a worldwide basis, except Japan. Lynx catheters are the latest generation of CVD's Focus Technology balloon dilatation balloon dilatation a technique that uses a catheter with an inflatable balloon to increase the diameter of the lumen of a structure such as the urethra or a heart valve. See balloon valvuloplasty. catheters. During conventional balloon angioplasty balloon angioplasty: see under angioplasty. , the dilatation dilatation /dil·a·ta·tion/ (dil?ah-ta´shun) 1. the condition, as of an orifice or tubular structure, of being dilated or stretched beyond normal dimensions. 2. the act of dilating or stretching. force required to treat atherosclerosis is distributed over the entire length of the balloon, directing the dilatation force not only at the diseased site but also upon the adjacent vessel wall. In contrast, the Lynx catheters "focus" the majority of the dilatation force more directly to the lesion site, sparing the surrounding arterial wall from potentially damaging balloon dilatation force. The Lynx catheters represent another advance in CVD CVD Cardiovascular disease, see there Focus Technology, providing further miniaturization min·i·a·tur·ize tr.v. min·i·a·tur·ized, min·i·a·tur·iz·ing, min·i·a·tur·iz·es To plan or make on a greatly reduced scale. min of every component of the catheter device. With reduced size of both the catheter shaft and balloon profile, the Lynx catheters will broaden the use of Focus Technology to new clinical situations and interventional procedures, increasing the total market potential for CVD Focus Technology. In addition, the Lynx catheters are the first CVD products using CVD's unique performed, extended-pressure Focus Balloon Technology. This technology allows the Lynx to be used in clinical procedures requiring moderate and high pressure dilatation. The Lynx catheters are clinically useful in both coronary balloon dilatation procedures and as an adjunct in other interventional procedures. Enforcer SDS 1. (company) SDS - Scientific Data Systems. 2. (tool) SDS - Schema Definition Set. Coronary Stents The Enforcer SDS system is the company's first product which executes CVD's Focused Stenting clinical strategy for coronary stent delivery. The CVD Enforcer stent is premounted on a specially-designed Focus Technology catheter delivery system. Focused Stenting improves upon conventional coronary stenting Coronary Stenting Definition A coronary stent is an artificial support device used in the coronary artery to keep the vessel open. Purpose by maximizing the arterial lumen diameter within the stent to provide greater coronary blood flow with no increase in patient complications, and reducing the number of catheters required to complete the stent delivery procedure. The Enforcer SDS system will be launched in all European countries prior to the end of 1997. Gottlieb Infusion System The Gottlieb Infusion System utilizes CVD's patented Bullett site-specific drug delivery technology in combination with a specially-designed coronary guidewire to access difficult to reach disease sites in patients with coronary atheroscleriosis. Such patients include those with severe atheroscleratic blockages located in the curved bends within the coronary anatomy, as well as patients with total blockages of the coronary vasculature vasculature /vas·cu·la·ture/ (vas´ku-lah-chur) 1. circulatory system. 2. any part of the circulatory system. vas·cu·la·ture n. . The Gottlieb Infusion System will be sold in both over-the-wire (Bullett OTW) and fast-exchange (Bullett FX) models and will be launched throughout the world, except Japan. Third Quarter Revenues Up, But Lower Than Expected CVD third quarter product sales are expected to be significantly increased compared to 1996 results. However, sales for the third quarter will be lower than planned due to three factors. As previously announced, CVD acquired its former German distributor in July. The company now only recognizes sales in Germany when products are sold and shipped to end-user hospitals, rather than when stocking orders are shipped to a distributor. Revenues for the third quarter would have been higher if the company had been shipping stocking orders for its new products to an independent distributor in Germany. Secondly, the company had expected that its ARC FX and Lynx catheters would be approved for marketing by the Japanese Ministry of Health during the third quarter and CVD could, therefore, resume product shipments to Japan through its new distribution partner, Cathex Ltd. However, approvals of these products and initial shipments will not begin during the third quarter. The company believes that these approvals will occur during the fourth quarter 1997. Lastly, none of the planned product shipments to one of CVD's former distributors, Medtronic Inc., will occur during the third quarter, negatively impacting revenue results. Commenting on third quarter revenues, Jeff O'Donnell, CVD president and chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. said: "The Japanese approval delays have certainly hurt third quarter revenues. "However, we expect initial shipments of CVD products to our new Japanese partner during the fourth quarter. "In the U.S., Medtronic was a good partner to help us launch our Fact and ARC catheters. Now, with a number of new products scheduled for launch in the U.S. and the rest of the world during the remainder of 1997 and 1998, we look forward to building our own distribution organizations, as we have initiated in Germany." CVD develops and markets coronary stents, stent delivery systems, balloon dilatation catheters, 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 products and minimally invasive devices for peripheral vascular applications. -0- NOTE: Except for the historical information contained herein, the matters discussed in this news release may be forward-looking statements, the accuracy of which is necessarily subject to risks an uncertainties. The receipt of regulatory approvals and clinical efficacy of, manufacturability of and market demand for products, among other matters discussed in this release, may cause actual results to differ significantly from the discussion of such matters in the forward-looking statements. Actual results may be affected by, among other things, risk and uncertainties related to new product development and introduction cycles, research and development activities, delays by regulatory authorities, scientific advances by CVD or third parties, introduction of competitive products, third party reimbursement and physician training, as well as those risk factors set forth in the CVD Form 10-K for the year ended Dec. 31, 1996. CONTACT: CardioVascular Dynamics Inc., Irvine Dana Nickell, 714/457-9546 |
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