Scott Huennekens, President and CEO of Volcano Corporation, added, "The successful completion of a FDA 510(k) by each of the companies represents both the culmination of months of product development collaboration, as well as the opportunity to begin commercializing Innova IVUS. We believe this fully integrated product will shorten procedure time that has been historically associated with IVUS and provide clinicians with easier access to important information provided by IVUS."

With more than 1,200 Innova all-digital x-ray systems installed worldwide, GE is poised to facilitate greater utilization of IVUS to further guide patient management. As the clinical relevance of IVUS has increased, particularly with the recent innovations in IVUS-based, real-time tissue characterization and IVUS/angio image co-registration, so too has the market need for an integrated, easy-to-use system.


Dr. Mark Wholey, MD, Chairman of the Pittsburgh Vascular Institute at the University of Pennsylvania Medical Center, elaborated, "When you have a catheterized patient on the table, you need your diagnostic and therapeutic tools to be ready -- there for quick and simple implementation. Many times it is just not an option to ask the staff to roll in the IVUS console, turn it on and wait for it boot up. We have been asking for this advance from the IVUS companies for some time now. We are thrilled that Volcano and GE have recognized the need and responded with this integrated product."

"IVUS, advanced 3D angiographic imaging techniques and non-invasive Imaging technologies such as MDCT and MRI hold the promise of unlocking many important mysteries surrounding the cause and progression of coronary and peripheral artery disease. Only by combining the information from several, if not all, of these modalities will we be able to gain a clear understanding of this disease. The integration of IVUS with Angio systems is an important step in making truly integrated imaging feasible and practical for a wide array of physicians," commented Rob Schwartz, MD, of the Minneapolis Heart Institute and Foundation.

Innova IVUS is currently available for sale to GE Healthcare customers and will be co-marketed by the GE and Volcano sales and marketing organizations in the United States, Europe, certain markets in Asia and other world markets. GE will also collaborate with Volcano to provide unparalleled cath lab design, installation and field repair/service of this new system. Current GE cath lab customers can modify existing cath lab rooms with the new integrated IVUS system. Customers will be able to contract with one vendor, GE, for their purchasing, installation and field service needs.

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