Intravascular imaging of coronary arteries continues to be refined, allowing physicians to more accurately assess lesion severity and confirm proper stent placement.
Although intravascular ultrasound (IVUS) and fractional flow reserve (FFR), both technologies that aid in this process, have long been available to augment angiography, systems were cumbersome and very few physicians had access.
Now, Volcano Therapeutics (San Diego) has reported U.S. and European launch of the s5-Revo and s5-FFR options for its s5i integrated Imaging platform. These two new product options enable rotational IVUS and FFR to operate on the same integrated system.
FDA approved in February, the point of these options is to make the physician's job easier, and diagnosis and treatment more accurate.
"IVUS or FFR confirm that you need to treat in the first place," Volcano's Vince Burgess, executive VP of marketing and business development told Diagnostics & Imaging Week, adding that practitioners have been routinely misled by using angiography alone to assess lesion severity and to confirm proper stent placement.
"Right now with angiogram, some lesions are clearly obstructed, or not. I would estimate half of images on angiograms are equivocal or questionable," he said. "With IVUS or FFR, you can intervene, and use the wire or catheter to determine extent of disease with much greater accuracy."
The picture is simply much clearer, Burgess said.
"Previously, to get an FFR measurement you needed a dedicated box and proprietary software," he said. "Although the technology and data you get is well documented as being helpful, the use of this technology has been low around the world."
Volcano's combined technology may now be available, but with a price range of $75,000 to $125,000 per cath lab suite, it might take a little while to populate all interventional labs.
"No other company provides a system that integrates this level of functionality and convenience in a single platform," Burgess said, adding that use of the technology is rapidly growing. He estimates that 15% of all percutaneous coronary interventions (PCIs) in the U.S. include intravascular ultrasound.
"IVUS use in the last two to three years has doubled from 7% to almost 15%," he said. "A key driver is the fact that all IVUS products — ours and our competitor's — are getting easier to use."
Boston Scientific's (Natick, Massachusetts) iLab Ultrasound Imaging System is Volcano's only competitor, Burgess said.
Earlier generation consoles included only one of the three technologies now available on the s5i. If a hospital wanted to equip a new lab with all three technologies, it would have to acquire three separate consoles, each with a different measurement modality, training requirements and data storage protocols.
The Volcano s5i can now accommodate the three primary intravascular diagnostic tools in regular use by cardiologists today (high frequency rotational IVUS, fast and simple phased array IVUS, and pressure-based FFR guidewires) on a single platform, making modern day imaging consoles more flexible than ever before.
The Volcano s5i Imaging System has been tested in cooperation with GE Healthcare (Waukesha, Wisconsin), Philips Medical Systems (Andover, Massachusetts), Siemens (Munich, Germany) and Toshiba America Medical Systems (Tustin, California) for safety and compatibility when used with their current lines of X-ray systems and equipment.
Last fall, Volcano reported raising about $123.3 million in its offering of 8.05 million shares of common stock at $16.25 a share.