GE and Volcano receive FDA clearance for integrated ultrasound and X-ray
30 August 2006
Waukesha, Wis. & Rancho Cordova, Calif.
USA. GE Healthcare (NYSE:GE) and Volcano Corporation (NASDAQ:VOLC) have
announced FDA 510(k) clearance for the integration of Volcano's
intravascular ultrasound imaging (IVUS) capabilities onto GE's 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.
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.
Scott Huennekens, President and CEO of Volcano Corporation, said,
"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
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
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.