CardioVascular Dynamics receives FDA clearance to market vascular access products.

IRVINE, Calif.--(BW HealthWire)--May 6, 1997--CardioVascular Dynamics Inc. (NASDAQ:CCVD) Tuesday announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin marketing the company's P.D. Access vascular access products in the United States.

This FDA clearance allows CVD to market three product variations of P.D. Access devices. The company believes that this technology will provide quicker, more accurate, and safer vascular access in a wide range of hospitalized patients including young children, infants, and the elderly who require surgery, critical care treatment, or neonatal intensive care.

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.

P.D. Access technology has been applied to three individual products. This FDA marketing clearance includes all three products in a 22 gauge needle size. The P.D. Access Needles will also be marketed in 18 and 20 gauge sizes.

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. -0-

CVD's primary target market during the next 1-2 years will be for critically ill pediatric patients. 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.

Commenting on the P.D. Access products, CVD Chairman and Chief Executive Officer Michael R. Henson said: "P.D. Access represents a new and significant business opportunity for CVD. The potential market for these products in pediatric patients is in excess of $100 million annually. Our goals over the next twelve months are to solidify and broaden the clinical foundation proving the value of P.D. Access, finalize our manufacturing processes to optimize our production yields and reduce manufacturing costs, and determine the most effective sales distribution vehicle for maximizing the market penetration of P.D. Access products in our target market."

In November 1996, CVD began a clinical usage trial to evaluate P.D. Access technology in comparison to conventional vascular access methods in pediatric patients. Early results have shown that P.D. Access may reduce trauma to the patient, save time, and reduce the costs of obtaining vascular access in these patients. CVD plans to expand this study to a number of clinical centers in the United States and abroad. Following completion of this clinical study, CVD will begin a geographically-based product launch of P.D. Access products. This limited launch is expected to begin during the third quarter 1997. Worldwide product launch will be completed by the end of the first quarter 1998.

Cynthia Reyes, M.D., chief of pediatric surgery at University of California, Irvine Medical Center commenting on her clinical experience with P.D. Access said, "Vascular access in the small patient can often be difficult and P.D. Access offers a less traumatic approach in these difficult patients."

CVD develops and markets site-specific drug delivery catheters, coronary stent delivery systems, balloon dilatation catheters for coronary and peripheral vascular use, 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 risk factors set forth in the CVD Form 10-K for the year ended Dec. 31, 1996.

CONTACT: CardioVascular Dynamics Inc., Irvine

Heather Murray, Investor Relations 

714/457-9546