Diagnostics & Imaging Week

In an agreement that had its beginnings with discussions late last year, GE Healthcare (Waukesha, Wisconsin) and Volcano (Rancho Cordova, California) last month reported what they are calling a "significant" development collaboration to bring an "industry-first" imaging capability to cardiac catheterization labs around the world.

GE and Volcano will cooperate in developing a digital cardiovascular imaging system with integrated intravascular ultrasound imaging (IVUS) capabilities, the companies said.

Bradley Fox, business manager for the Interventional, Cardiology and Surgery business at GE Healthcare, in an e-mail response to Diagnostics & Imaging Week, said that project resulted from exploratory discussion in 2004, "exchanging views on the marketplace and directions we were headed with our product lines. We found that we have a very similar view of where interventional cardiology is heading and that we both felt strongly that integration within the cath lab would be a major factor in both improving workflow and in enabling and optimizing new procedures."

The integration of GE's Innova all-digital X-ray cath lab system with Volcano's new PC-based IVUS platform focuses on providing a precise view of coronary and peripheral vessel morphology for the interventional cardiologist. That capability will assist in determining the extent of cardiovascular disease to guide therapeutic procedures, such as stent placement, by determining the exact lesion length and stent length.

"Our integration will be based on Volcano's S5 device," introduced at the recent Transcatheter Cardiovascular Therapeutics meeting in Washington, Fox said.

The imaging device produced, he said, will be co-developed by Volcano's team in Rancho Cordova and GE Healthcare's cardiovascular X-ray team in Buc, France.

Fox said the combination of Volcano's IVUS system and the GE Innova family of interventional suites will be "the first of its kind. Today, clinicians are realizing that intravascular imaging can play a significant role in the success of [drug-eluting stent] deployment – allowing them to assess disease beyond the 'narrowing' visible on the angiogram."

He added that a decision not to use IVUS "is heavily influenced by the workflow impact of having to wheel in and set up the IVUS system. The displays and data management are also not integrated."

By contrast, the combining of technologies "allows the use of IVUS to be integrated into the workflow [to] simply select and plug in an IVUS catheter – the system will always be there, controlled from tableside with display integrated in the overhead monitors."

Scott Huennekens, president and CEO of Volcano, said in statement, "We have a shared philosophy with GE [that] success in the marketplace is founded on providing solutions that are both state-of-the-art and simple to use." He said the goal of the collaboration is not "technology for technology's sake," but rather "meeting the clinical needs of our customers in a way that also simplifies their lives and makes their own cath lab operations more efficient and more cost-effective – all while allowing the physician to improve patient care."

Volcano says its latest PC-based IVUS platform "dramatically reduces the size, weight and noise of the IVUS console, allowing the unit to be easily attached to the patient table, in the control room or in other areas outside of the daily traffic pattern of the cath lab."

With more than 1,200 Innova all-digital X-ray systems installed worldwide, the companies say there is a clear market need for this type of integrated system.

William Wijns, MD, co-director of the Cardiovascular Centre (Aalst, Belgium), elaborated on the need for integration: "When you have a catheterized patient on the table, often in the midst of an acute syndrome, you need your diagnostic and therapeutic tools at the ready ... Many times it is just not an option to ask the staff to roll in the IVUS, turn it on and wait for the system to boot up. We have been asking for this advance from the IVUS companies for some time now."

GE also will collaborate with Volcano to provide 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.

According to Fox, GE Healthcare expects the integrated product to be available by 2Q06.

"The GE Innova systems and the Volcano S5 system have both received 510(k) clearance from the FDA," Fox said in his e-mail. "We are evaluating what additional regulatory actions will be required for the integrated product."

After receiving U.S. and international clearances, the system will co-marketed by the GE and Volcano organizations.

Volcano also reported last month that it had reached an agreement with Paieon (New York) to jointly develop products allowing an in-the-cath-lab combination of X-ray angiography (in both 2-D and 3-D views) with intravascular ultrasound in the cath lab.

The Volcano/Paieon system is expected to allow physicians and their staff to quickly assess regions of the coronary tree and simultaneously visualize both the patency of the arterial lumen and the presence, quantity and type of coronary atherosclerotic plaques.

The companies said that the new composite coronary imaging technology will fuse the images and information from angiograms and ultrasound, making the product fast, simple and readily available to research centers and community hospitals alike.

Volcano said it plans to offer the angio/IVUS image fusion system as an option for installation and use on its new and existing installed base of InVision Gold IVUS imaging consoles. It added that the ability to retrofit its large installed base of IVGs with this software option "should speed its proliferation into clinical practice."