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Volcano PrimeWire Prestige Pressure Guide Wire Receives FDA Clearance, CE Mark Approval

Volcano Corporation has received both FDA 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.

PrimeWire Prestige Pressure Guide 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 US and European sites. Commercial launch of the PrimeWire Prestige is expected in June 2010.

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.

Scott Huennekens, president and CEO of Volcano, said: “The first PrimeWire Prestige Pressure Guide Wire cases underline our commitment to delivering innovation and choice to our customers and patients. 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.”