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News

GE & Volcano corporation announce FDA clearance of fully-integrated Intravascular ultrasound

AZDEL : 24 August, 2007  (Company News)
GE Healthcare and Volcano Corporation today announced FDA 510(k) clearance for the integration of Volcano's intravascular ultrasound imaging capabilities onto the best-of-class Innova all-digital X-ray cath lab imaging system. This state-of-the-art digital cardiovascular imaging system is designed to give interventional cardiologists and interventional radiologists a clearer view of coronary and peripheral vessel morphology in a more accessible manner than previously available.
The integrated product, which the companies will commercialize under the name 'Innova IVUS', is a direct result of the agreement entered into by GE Healthcare and Volcano Corporation in March 2006. It is made possible, in part, due to Volcano's latest PC-based IVUS platform that reduces the size, weight and noise of the IVUS console, allowing the unit to be located in the control room or in other areas outside of the daily traffic pattern of the cath lab. The integrated user interface optimizes workflow when performing IVUS, and is designed to make the process markedly faster and easier.

'This technological development heralds a new beginning for advanced, real-time imaging in the cardiac catheterization laboratory,' said Laura King, Global Vice President and General Manager, Interventional, Cardiology and Surgery of GE Healthcare. 'It is also further evidence of GE Healthcare's continued commitment to cardiology by bringing state-of-the-art, clinically-relevant technologies to the cath lab.'

With integrated IVUS, clinicians have easier access to imaging tools that can help them better determine the extent of cardiovascular disease and assist in performing therapeutic procedures such as stent placement and assessment. It is also intended to help physicians determine the length of lesion as well as optimal stent length and diameter.

Innova IVUS allows clinicians to access IVUS commands on the Innova Central touchscreen. Clinicians have the option of using additional IVUS control devices as well, such as a trackball or joystick. The IVUS Patient Interface Module can hang on the bed rail while the IVUS CPU is located away from lab traffic in the control room. The patient information automatically transfers from the Innova System to the IVUS, eliminating the need to manually enter patient data. Clinicians have the flexibility to view IVUS images on the existing monitor bank, a separate, dedicated IVUS monitor and/or a monitor in the control room. By integrating with the lab's archiving system, Innova IVUS cases are stored as sub-studies along with the cath lab study, further facilitating access to all patient information, which is particularly useful for prior study comparisons.

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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