GE Healthcare (Waukesha, Wisconsin) and Volcano (Rancho Cordova, California) reported 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 – the first time such systems have been integrated.

GE said that the 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.”

“This is truly a first,” GE Marketing Manager Anita Makhija for the cardiac X-ray system, told Medical Device Daily. “There have been IVUS systems available in the past, and of course, imaging systems have been used for several years. But this is the first time in the industry that we have an integrated product.”

The integrated product, which the companies will commercialize under the name “Innova IVUS,” comes as a direct result of the agreement entered into by GE Healthcare and Volcano in March (Medical Device Daily, March 14, 2006). That agreement was reported at this year's meeting of the American College of Cardiology (ACC; Bethesda, Maryland).

“This partnership and this development we have done with Volcano really is going to be giving us a chance to give our customers advanced, real-time imaging in the cath lab,” Makhija said. “They will be able to conduct therapeutic procedures right at the tableside. It's going to be really easy to use, be simple . . . and it's basically just helping [clinicians] integrate their workflow much better.”

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.

Makhija said that previously, when Volcano's IVUS was sold on a stand-alone basis, it required moving a 480-pound system into the cath lab. Because it was also “very difficult to turn on the system,” only 12% to 15% of the interventional cases done were routinely using IVUS.

Now, however, “we've kind of changed the game by integrating it,” she said. What that means on an everyday basis for using it is that when a cardiac cath patient comes into the cath lab, the system automatically pulls in the IVUS information.

With integrated IVUS, clinicians are expected to 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 also is 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. Previously, the IVUS was the stand-alone system.

The IVUS Patient Interface Module (PIM) can hang on the bedrail while the IVUS CPU is located away from lab traffic in the control room, GE said.

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.

GE has the “largest installed base of flat-panel detectors – over 1,200 installed globally,” Makhija said, noting that there is a “huge opportunity to bring to our customers this integrated solution.”

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.

“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 at 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.”

Scott Huennekens, president/CEO of Volcano, 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.”

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, GE said.

Mark Wholey, MD, chairman of the Pittsburgh Vascular Institute , 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 to 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 3-D 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,” said 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 U.S., Europe, certain markets in Asia and other world markets and is expected to be available to customers beginning in September.

GE said it also would collaborate with Volcano to provide “cath lab design, installation and field repair/service of this new system.”