FDA approves new angioplasty technology of CardioVascular Dynamics.

IRVINE, Calif.--(BUSINESS WIRE)--Oct. 6, 1995--CardioVascular Dynamics Inc. (CVD), a subsidiary of Endosonics Corporation (NASDAQ: ESON), announced today that it has received notification from the U.S. Food and Drug Administration (FDA) granting the company approval to market its FACT coronary balloon angioplasty catheters in the United States.

The FACT was approved as a Premarket Approval (PMA) Supplement.

The FACT (FOCAL Angioplasty Catheter Technology) utilized CVD's FOCAL Expansion Technology to perform Percutaneous Transluminal Coronary Angioplasty (PTCA) using both low and high balloon inflation pressures within a single catheter.

This FDA approval will enable CVD to market the FACT catheters for coronary (heart) angioplasty applications. Clinical trials for these applications have shown that the FACT can both perform PTCA and enhance the efficacy of other interventional coronary procedures in a wide variety of clinical settings requiring PTCA.

In total, four models of FACT catheters were approved by the FDA within this submission.

CVD plans to introduce the FACT catheters at the annual American Heart Association (AHA) meetings to be held beginning on Nov. 12, 1995. The company plans to begin manufacturing FACT catheters during the fourth quarter of 1995 and initiate U.S. distribution in early 1996.

CVD FOCAL Expansion Technology

CVD FOCAL Expansion Technology has been in development for over three years by CVD Research Engineers.

In conventional balloon angioplasty, the dilatation pressure required to treat atherosclerotic blockages is distributed over the entire length of the balloon dilatation device, directing the dilatation pressure not only at the diseased site but also inflicting this high pressure upon the surrounding, healthy arterial wall structure.

In contrast CVD FOCAL Expansion Technology "focalizes" the majority of the dilatation pressure directly to the site of the blockage, sparing the surrounding healthy arterial wall from damaging balloon dilatation pressure.

Therefore CVD FOCAL Expansion Technology targets the balloon dilatation pressure directly at the disease while minimizing the damage to the adjacent vessel wall normally experienced with conventional balloon angioplasty.

CVD has conducted a series of scientific in-vivo animal trials comparing FOCAL Expansion Technology with conventional balloon angioplasty technology currently marketed by a number of manufacturers.

The results of these comparative trials confirm the ability of FOCAL Expansion Technology to effectively perform balloon dilatation while causing significantly less arterial damage than conventional balloon technology.

Human clinical trials have confirmed the safety and efficacy of this technology. CVD is continuing ongoing animal and human studies to further investigate the clinical value of this technology.

CVD has filed multiple patents on FOCAL Expansion Technology in both the United States and foreign countries. The company anticipates issuance of one or more of these patents.

First Major Advance in Balloon Technology in Five Years

Commenting on this FDA approval, Endosonics Chairman Michael Henson said, "CVD has spent considerable resources to develop and prove the value of the FACT catheters. We believe CVD's FOCAL Expansion Technology is the first major advance in balloon angioplasty technology in at least five years.

"Our clinical results indicate that this technology has meaningful clinical advantages over conventional balloon angioplasty. We anticipate that these catheters represent the first generation of a broad series of products utilizing CVD's proprietary FOCAL Expansion Technology."

Endosonics develops and markets intravascular imaging systems, diagnostic imaging catheters and combined angioplasty-imaging catheters. CVD develops and markets site-specific drug delivery catheters, combined angioplasty-drug delivery catheters and advanced therapeutic catheters.

CONTACT: Cardiovascular Dynamics Inc.

Heather Murray, 714/457-9546