PrimeWire PRESTIGE Pressure Guide Wire receives 510(k) clearance, CE Mark approval

Volcano Corporation (Nasdaq: VOLC) announced today it received both 510(k) clearance and CE Mark approval for its PrimeWire PRESTIGE™ Pressure Guide Wire for use with patients who have both single-vessel and multi-vessel disease. This next generation pressure wire is compatible with Volcano's full suite of integrated multi-modality consoles and stand-alone physiology systems as well as various hemodynamic monitoring systems. The first clinical cases with the device have taken place at various U.S. and European sites. Commercial launch of the PrimeWire PRESTIGE™ is expected in June 2010.  

"The first PrimeWire PRESTIGE™ Pressure Guide Wire cases underline our commitment to delivering innovation and choice to our customers and patients," said Scott Huennekens, President and CEO of Volcano Corporation. "Our goal is to provide simple, easy-to-use products that address the complex challenges, like multi-vessel disease, that clinicians encounter each day. Multiple blockages usually have more tortuous tissue to navigate through, take longer to address, and may require more devices passing over-the-wire to deliver treatment. The PrimeWire PRESTIGE™ is an advanced wire designed to help guide multi-vessel disease decision-making."

"The clinical data from the FAME study supporting the use of FFR to guide stent placement in multi-vessel disease patients is very strong, and has led to the upgrade of ACC/AHA/SCAI guidelines to level of evidence A," commented Dr. Mort Kern, Chief of Cardiology for the VA Long Beach Health System and Associate Chief of Cardiology at UC-Irvine Medical Center. "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 multi-vessel disease lesions easier and faster is a welcome change to physicians."

The PrimeWire PRESTIGE™ Pressure Guide Wire has a redesigned core intended to improve mechanical performance, such as torque transmission, vessel navigation, and support. A recent internal study confirmed that PRESTIGE™ substantially outperformed the previous generation PrimeWire® with respect to torque transmission. The redesigned tip also improves tactile feel and tip shape memory.  PrimeWire PRESTIGE™ will launch simultaneously with the new upgraded v3.2 Software for the Volcano s5i, which provides an optimized FFR workflow for ease of use.

CE Mark approval allows Volcano to market PrimeWire PRESTIGE™ in certain international markets, primarily in Europe. Volcano also has 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market PrimeWire PRESTIGE™ in the U.S.

"The PrimeWire PRESTIGE™ represents a significant improvement in performance to the previous generation FFR wire," commented Dr. Hoang Thai, Director, Cardiac Catheterization Laboratory and Interventional Cardiology, Southern Arizona Veterans' Affairs Health Care System Medical Center and Associate Director, Interventional Cardiology Fellowship Program Sarver Heart Center, University of Arizona. "I have been committed to using FFR in these complex patients for some time, and it is great to see a product evolving along with my practice to make my decision-making in the cath lab easier and more predictable."

SOURCE Volcano Corporation