CardioVascular Dynamics receives FDA approval to launch Lynx catheters in the United States for coronary use.

IRVINE, Calif.--(BW HealthWire)--April 16, 1997--CardioVascular Dynamics Inc. (NASDAQ:CCVD) Wednesday announced that it has received approval from the U.S. Food and Drug Administration (FDA) to begin marketing the company's Lynx catheters in the United States.

This FDA clearance allows CVD to market eight new different models of Lynx over-the-wire catheters.

The Lynx catheters utilize CVD's Focus Technology to treat atherosclerosis blocking blood flow within coronary arteries. Focus Technology is CVD's patented, multi-diameter balloon technology that provides a versatile device that can perform interventional procedures using both low and high balloon inflation pressures on a single catheter.

During conventional balloon angioplasty, the dilatation 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 "focalize" 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 Focus Technology, providing further miniaturization 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.

A university animal trial compared CVD Focus Technology catheters with conventional balloon dilatation catheters marketed by a number of manufacturers. The investigators concluded that the use of the Focus Technology resulted in less arterial damage than conventional balloon technology.

At the recent American Heart Association Meeting, scientific data was presented from a randomized clinical trial conducted by a major European cardiology center highlighting results in over 300 patients. This study confirms previous clinical trials proving that CVD Focus Technology enables the cardiologist to improve acute clinical outcomes in interventional coronary patients with no increase in patient complications, and a reduction in both the number of catheters used per patient and total hospitalization costs. CVD is continuing human clinical trials to further investigate the clinical value of Focus Technology.

Commenting on this approval, Michael Henson, CVD chairman and chief executive officer said, "The Lynx catheters answer the questions many cardiologists have asked concerning Focus Technology. The Lynx offers state-of-the-art low balloon profile, very high burst pressures and a miniaturized catheter shaft. Clinical results have been impressive. We expect the Lynx catheters to become a major product for CVD."

CVD develops and markets site-specific drug delivery catheters, combined angioplasty-drug delivery catheters, coronary stent delivery catheters and vascular access products. -0-

NOTE TO EDITORS: 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 and 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 factors set forth in the CVD prospectus, dated June 19, 1996. -0-

CONTACT: CardioVascular Dynamics Inc., Irvine

Heather Murray, 714/457-9546