EndoSonics Launches Five-64 Series Catheters at American Heart Association Meeting; Sets New Standard for Intravascular Ultrasound Image Quality.
These new products have been cleared for marketing by the U.S. Food and Drug Administration.
As part of the "Pinnacle" Development Project, the Five-64 design utilizes five patented micro processing chips and sixty-four discrete ceramic imaging elements in a 3.5 Fr. size catheter. This product is designed to run on the EndoSonics digital Oracle Imaging System which together with the new Five-64 series catheter generates ultrasound images unavailable with current mechanical technology. Superior near and far field resolution is achieved due to EndoSonics' proprietary dynamic aperture array (DAA) architecture.
Commenting on the three year "Pinnacle" Development Project, EndoSonics' Sr. Vice President of Engineering Mike Eberle states: "Many people said that the technical and development issues required to design a catheter with this many discrete elements and signal processing capability would be years off. I am proud that the EndoSonics' team has overcome these significant technical hurdles to deliver this new standard in intracoronary ultrasound images."
Because EndoSonics advanced solid state catheter has no moving parts, there is no NURD (non-uniform rotation distortion) effect. The NURD effect associated with mechanical devices can cause measurement inaccuracies. In addition, solid state catheters are much more flexible than competitive mechanical devices offering handling characteristics compatible to standard PTCA balloon catheters. The catheter shaft is a coaxial, over-the-wire design which provides pushability, trackability, and safety as compared with competitive mechanical devices.
The FDA action to approve the 510(k) application for these products allows EndoSonics to begin marketing several versions of the Five-64 diagnostic imaging catheters. EndoSonics will begin shipping the new Five-64 catheter in limited quantities in the first half of 1996. The company is building a new automated manufacturing facility in Rancho Cordova, Calif., to meet the increasing demand for intracoronory ultrasound. Production quantities from this plant are expected in late 1996.
Additional Pinnacle project developments which build upon the company's new imaging technology include: combination devices (imaging/high pressure PTCA balloons and coronary stent delivery systems), the first intravascular color flow, new digital user interface option, and software packages for 3D reconstruction, report writing, and tissue characterization/analysis.
EndoSonics Corp. develops and markets intravascular imaging systems, diagnostic imaging catheters and combined angioplasty-imaging catheters. CardioVascular Dynamics Inc., EndoSonics' majority-owned subsidiary, develops and markets site-specific drug delivery catheters, combined angioplasty-drug delivery catheters and advanced therapeutic catheters.
CONTACT: EndoSonics Corp.
Don Fraley, 916/638-8610
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|Date:||Nov 9, 1995|
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