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GE Healthcare and Volcano Vorporation Announce FDA Clearance of Intravascular Ultrasound Imaging on the Innova Platform

by Barbara Kram, Editor | August 24, 2006
Waukesha, WI and Rancho Cordova, CA -- GE Healthcare (NYSE: GE) and Volcano Corporation (NASDAQ: VOLC) today announced FDA 510(k) clearance for the integration of Volcano's intravascular ultrasound imaging (IVUS) 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 (PIM) 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.