Endosonics receives FDA go-ahead to market five new FOCUS angioplasty catheters.
The FOCUS utilizes CVD's FOCAL Technology to perform Percutaneous Transluminal Angioplasty (PTA) 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
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|Date:||Jul 18, 1995|
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