Volcano Corporation’s PrimeWire PRESTIGE Pressure Guide Wire has received 510(k) clearance from the US Food and Drug Administration (FDA) and CE Mark approval.
The PrimeWire PRESTIGE is an advanced wire for use on patients with single-vessel and multi-vessel disease.
The device has a redesigned core to improve mechanical performance, such as torque transmission, vessel navigation and support.
Clinical trials on the device were conducted at various US and European sites.
PrimeWire PRESTIGE will be launched commercially in June 2010.