Volcano Announces FDA 510(k) Clearance of Revolution Rotational Catheter and FFR for the s5i Integrated IV...(he s5-Revo and s5-FFR launch Volcano has...)

Date:2/7/2008

he s5-Revo and s5-FFR launch, Volcano has increased its training offering to incorporate more robust site education on all three of these primary technologies. Housing three diverse diagnostic tools on the same console not only increases access to the technology but streamlines and simplifies staff training, as all three tools are run through the same, consistent user interface.

Craig A. Thompson, MD, MMSc and the Director of the Cardiovascular Catheterization Laboratory at the Dartmouth-Hitchcock Medical Center commented, "As a major teaching institution for Interventional Cardiologists, it is our responsibility to ensure every trainee is versed in the full line of diagnostic modalities available to improve patient care. The Volcano system will allow us to improve exposure to various IVUS and FFR applications through a common interface, which will enrich our training programs and the acumen of our fellows moving forward."

Availability

The first installations of the Volcano s5-Revo and s5-FFR Options under a limited market release strategy will commence shortly with a full market release expected in the first half of 2008. The Volcano s5-Revo and s5-FFR options complement the existing s5 functionality, including ChromaFlo(R) for stent apposition assessment, and VH(TM) IVUS plaque composition analysis.

The Volcano s5 Imaging System has been tested in cooperation with GE, Philips, Siemens and Toshiba for safety and compatibility when used with their current lines of x-ray systems and equipment. The Volcano s5 has also been tested for compatibility with eleven different DICOM providers, and for Worklist compatibility with image storage in the same patient "jacket" as the angiogram.

About Volcano Corporation

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