Endosonics receives FDA go-ahead to market five new FOCUS angioplasty catheters.PLEASANTON, Calif.--(BUSINESS WIRE)--July 18, 1995--Endosonics Corporation (NASDAQ NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ESON) announced today that its CardioVascular Dynamics, Inc. (CVD CVD Cardiovascular disease, see there ) subsidiary has received notification from the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) of U.S. marketing approval of its Premarket Notification (510k) submission for five catheter models of its FOCUS small vessel angioplasty catheters.
The FOCUS utilizes CVD's FOCAL Technology to perform Percutaneous Transluminal transluminal /trans·lu·mi·nal/ (trans-loo´mi-n'l) through or across a lumen, particularly of a blood vessel.
Passing or occurring across a lumen. Angioplasty (PTA PTA or parent-teacher association: see parent education. ) using both low and high balloon inflation pressures with a single catheter. This FDA action will enable CVD to market the FOCUS catheters for peripheral vascular angioplasty applications in small vessels. Clinical trials for these applications have shown that the FOCUS can perform angioplasty successfully in a wide variety of clinical settings.
This recent FDA action allows CVD to begin marketing an additional five models of FOCUS catheters in the U.S., bringing the total number of approved FOCUS catheter models to eight. The Company plans to introduce these FOCUS catheters on a worldwide basis by the end of 1995.
Commenting on these approvals, Endosonics Chairman Michael Henson said, "We have obtained agreement from the FDA to market eight FOCUS catheters in the past six months, significantly ahead of our business plan. We plan to begin initial production of FOCUS catheters in limited quantities during the third quarter and launch all eight catheter models by the end of 1995."
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: Endosonics Corporation
Donald Huffman, 510/734-0464