CardioVascular Dynamics Receives FDA Go-Ahead to Market Vascular Access Devices for Newborn Children.

IRVINE, Calif.--(BW HealthWire)--March 10, 1998--CardioVascular Dynamics Inc. (Nasdaq: CCVD) Tuesday announced that it has received allowance from the Food and Drug Administration (FDA) to begin U.S. marketing of its P.D. Access products in sizes appropriate for use in hospitalized newborn children (i.e., neonates) requiring vascular access.

Commenting on this technology, Cynthia Reyes, M.D., chief of Pediatric Surgery at the University of California, Irvine and a clinical investigator of P.D. Access products said "Vascular access in the small patient can often be difficult and P.D. Access offers a less traumatic approach in these difficult patients."

P.D. Access technology involves the use of a tiny Doppler Ultrasound circuit placed at the tip of a specially-designed vascular access needle or catheter. During the past two years, CVD engineers have miniaturized this Doppler chip technology to less than 10 thousands of an inch (0.010-inch). This small size is required to locate the tiny arteries and veins of small infants.

When placed in proximity to the vascular system, P.D. Access devices can help the pediatric specialist locate the blood vessel, determine whether the vessel is an artery or vein, and provide access to the intended vascular site. Once in position within the vessel, the physician can begin the planned treatment via the conduit created by the P.D. Access device.

This recent positive action by the FDA will allow CVD to begin marketing a number of models of P.D. Access doppler probes and needles that are 22mm and 24mm gauge in size. These miniaturized devices are small enough to enter the tiny veins and arteries of children from one to 10 pounds in size.

Such young children and small infants frequently require multiple vascular access locations and many times have difficult-to-locate venous and arterial sites. The company believes that over 15 million pediatric vascular access procedures are conducted each year in the United States, with a similar number of annual procedures completed in international markets.

P.D. Access products will be available in a number of product configurations: -0- P.D. Access Needle

The P.D. Access needle is useful to gain access to the central venous circulation to facilitate catheter placement for the administration of various drugs (e.g., antibiotics), chemotherapeutic agents, and nutritionals.

P.D. Access Over-the-Needle Catheter (ONC)

The most common applications of the P.D. Access ONC are peripheral lines or vascular access for short-term administration of intravenous solutions and drug therapy. When placed in an artery, the ONC is also useful for measuring arterial pressure or obtaining samples for blood gas analysis.

P.D. Access Peel-Away Needle Introducer

The P.D. Access with Peel-Away Introducer is often used to place central venous lines in infants for long-term intravenous delivery of medications. Similarly, in older patients, the Peel-Away Introducer is used to place central venous catheters via the brachial approach.

CVD plans to begin manufacturing these new small P.D. Access Products in limited quantities during the second quarter of 1998. The company expects full worldwide market release during the fourth quarter 1998.

CVD develops and markets coronary stent delivery systems, balloon dilatation catheters for coronary and peripheral vascular use, site-specific drug delivery catheters, and vascular access products. -0-

Except for the historical information contained herein, the matters discussed in this news release may contain forward-looking statements, the accuracy of which are 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 and those other risk factors and other items set forth in the company's Form 10-K/A for the year ended Dec. 31, 1996 and the company's Quarterly Reports on Form 10-Q for the quarters ended March 31, 1997, June 30, 1997 and Sept. 30, 1997.

CONTACT: CardioVascular Dynamics Inc., Irvine

Dana Nickell, 714/457-9546