CardioVascular Dynamics begins clinical trial for vascular access technology in critically ill children.

IRVINE, Calif.--(HealthWire)--Nov. 20, 1996--CardioVascular Dynamics Inc. (NASDAQ:CCVD) on Wednesday announced that it has initiated a worldwide clinical trial to study its patented vascular access technology in critically ill infants.

The company believes that this technology, named P.D. Access, will provide quicker, more accurate and safer vascular access in young infants (i.e., as young as one-day old) undergoing surgical procedures, pediatric intensive care treatment and in neonatal procedures.

P.D. Access technology involves the use of a tiny doppler ultrasound crystal placed at the tip of a conventional vascular access needle or catheter. During the past two years, CVD engineers have been miniaturizing this doppler crystal chip technology to sizes appropriate for pediatric clinical applications.

CVD has now achieved miniaturization of this chip to a size equal to nine thousandths (0.009) of an inch. The company believes such small sizes are necessary to locate and identify the tiny, delicate blood vessels in small infants (i.e., as small as one pound body weight). CVD has a worldwide license to manufacture and sell all products utilizing P.D. Access crystal chip technology.

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 immediate access to the proper vessel. Once in position within the vessel, the physician can begin the planned treatment via the conduit created by the P.D. Access device.

Such treatment includes antibiotic therapy, nutritional feeding and/or the delivery of various chemotherapeutic agents.

In the past month, CVD has begun a clinical trial to evaluate this technology for pediatric applications. This trial will be a worldwide, multi-center clinical utilization study comparing the P.D. Access technology to conventional vascular access devices. The criteria for evaluation in this study will be time savings, degree of trauma to the child, reduced anesthesia time and comparative cost savings.

Commenting on CVD's P.D. Access technology, CVD Chairman and Chief Executive Officer Michael Henson said, "I have witnessed the use of P.D. Access to gain vascular access in small infants. The potential clinical value of this technology in reducing trauma and anesthesia time in these small children is quite compelling.

"Now, we need to answer the question of whether or not this clinical value is significant when these devices are used in a broad spectrum of clinical situations."

If these trials are successful, CVD plans to market the P.D. Access products in foreign countries, including Europe and Japan, in mid-1997. Based upon FDA submission and approval, P.D. Access product launch in the United States may begin in late 1997.

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

NOTE: 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, manufacturing 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.

CONTACT: CardioVascular Dynamics Inc., Irvine

Heather Murray, 714/457-9546