Volcano's PrimeWire Prestige Cleared in US and Europe

May 19, 2010—Volcano Corporation (San Diego, CA) announced that it received both US Food and Drug Administration 510(k) clearance and European CE Mark approval for the PrimeWire Prestige fractional flow reserve (FFR) pressure guidewire for use with patients who have both single-vessel and multivessel disease. The first clinical cases with the device have been completed. A commercial launch in the United States and Europe is expected in June 2010. PrimeWire Prestige will launch simultaneously with the company's upgraded v3.2 software for the Volcano s5i, which provides an optimized FFR workflow for ease of use.

According to the company, this next-generation pressure wire is compatible with Volcano's full suite of integrated multimodality consoles and stand-alone physiology systems, as well as various hemodynamic monitoring systems. The PrimeWire Prestige has a redesigned core intended to improve mechanical performance, such as torque transmission, vessel navigation, and support. The redesigned tip also improves tactile feel and tip-shape memory.

“The clinical data from the FAME study supporting the use of FFR to guide stent placement in multivessel disease patients is very strong and has led to the upgrade of ACC/AHA/SCAI guidelines to level of evidence A,” commented Mort Kern, MD. “One key hurdle that physicians continuously battle with is the accurate and efficient diagnosis of lesion significance at the time of the procedure. Any improvement to the performance of today's FFR wires that make assessment of multivessel disease lesions easier and faster is a welcome change to physicians.”