CardioVascular Dynamics Begins International Clinical Trials For New S.E.A.L. Technology Devices.IRVINE, Calif.--(BW HealthWire)--June 25, 1998--CardioVascular Dynamics Inc. (Nasdaq: CCVD CCVD Communauté de Communes du Val de Drôme CCVD Combustion Chemical Vapor Deposition ) Thursday announced that it has begun clinical trials in Europe using its new Self Expanding Arterial Liner (SEAL(TM)) Technology to treat peripheral vascular disease Peripheral Vascular Disease Definition Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. . CVD CVD Cardiovascular disease, see there believes that its SEAL(TM) Technology represents a new generation of cardiovascular implant devices to treat atherosclerosis. Building on the knowledge foundation gained from its Focus Stenting products, CVD's investigation hopes to prove the design of the SEAL devices overcome certain problems associated with conventional peripheral vascular stent implant devices. Currently, conventional balloon expandable stent devices are deployed into the arterial wall with 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. pressure. The SEAL Technology uses novel metallic-based materials formed in a manner that self expands to provide an integral covering, or lining, over the diseased arterial wall. The SEAL devices are designed to provide a gentle, continuous pressureto maintain the patency pa·ten·cy n. The state or quality of being open, expanded, or unblocked. patency the condition of being open. of the arterial lumen. The SEAL Technology contains up to 10 times more metallic content than existing stents. This high concentration of metal is expected to provide a natural barrier to the hyperplastic regeneration of intimal intimal pertaining to or emanating from vascular intima. intimal bodies irregular mineralized masses covered by endothelium and protruding into the lumen of small arteries and arterioles of horses, especially in the intestinal tissue growth that occurs following traditional balloon angioplasty balloon angioplasty: see under angioplasty. and conventional stent implantation. The company has conducted numerous laboratory and animal studies at multiple university sites to evaluate the acute and long-term effects of its SEAL Technology. Comparison of these studies with published results obtained with conventional balloon expandable stents suggests the vascular anatomy may respond quite differently to SEAL Technology. Commenting on the company's plans for SEAL Technology, CVD President and Chief Executive Officer Jeffrey O'Donnell said: "Our SEAL devices look different and behave differently within the arterial circulation than conventional stent technology. Conventional balloon expandable stenting still results in restenosis rates of 30-50% among many types of patients. Our next goal is to prove the ability of SEAL Technology in improving such long-term clinical outcomes. We have initiated clinical trials for peripheral vascular applications in Europe. By the end of the year, we hope to begin clinical trials using SEAL devices in selected coronary indications." CVD has seven issued patents and numerous patent applications covering SEAL Technology devices. CVD expects to begin marketing some models of products based on its SEAL Technology outside the United States during 1999. CVD develops peripheral and coronary stents, coronary stent delivery systems, balloon dilatation catheters for coronary and peripheral vascular use, site-specific drug delivery catheters, and 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. Except for historical information contained herein, this news release contains forward looking statements, the accuracy of which are necessarily subject to risks and uncertainties. Actual results may be affected by, among other things, risks and uncertainties related to new product development and introduction cycles, research and development activities, including failure to demonstrate clinical efficacy, delays by regulatory authorities, scientific and technical advances by CVD or third parties, introduction of competitive products, third party reimbursement and physician training, and other risk factors and matters set forth in the company's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended Dec. 31, 1997 and the company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 1998.
CONTACT: CardioVascular Dynamics Inc.
Stephen R. Kroll, 949/457-9546
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