CardioVascular Dynamics Receives FDA Approval to Launch Guardian Coronary Catheters in United States.

IRVINE, Calif.--(BW HealthWire)--June 8, 1998--CardioVascular Dynamics Inc. (Nasdaq: CCVD) Monday announced that it has received approval from the United States Food and Drug Administration (FDA) to begin marketing the company's Guardian(TM) catheters.

The Guardian 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 Guardian 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 Guardian 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 Guardian 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 Guardian catheters are the first CVD products available in the United States using CVD's unique preformed, extended-pressure Focus Balloon Technology. This technology allows the Guardian to be used in clinical procedures requiring moderate and high pressure dilatation. The Guardian catheters are clinically useful in both coronary balloon dilatation procedures and as an adjunct in other interventional procedures (e.g. rotational atherectomy, coronary stenting).

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 a recent international cardiology meeting, scientific data was presented from a clinical trial conducted at seven major cardiology centers in the United States. This study confirms previous clinical trials proving that CVD Focus Technology enables the cardiologist to improve acute clinical outcomes in interventional coronary procedures with no increase in patient complications compared with conventional balloon dilatation devices. CVD is continuing human clinical trials to further prove the clinical value of Focus Technology.

Commenting on this approval, Jeff O'Donnell, CVD chief executive officer said, "The Guardian catheters answer the questions many cardiologists have asked concerning Focus Technology. The Guardian 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 Guardian catheters to become a major product for CVD in the United States."

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 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 for the year ended Dec. 31, 1997 and the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 1998.

    CONTACT:  CardioVascular Dynamics Inc., Irvine
               Stephen R. Kroll, 949/457-9546