EndoSonics wins clearance for Trak Back

Intravascular ultrasound developer EndoSonics has received Food and Drug Administration clearance for its disposable pull back device, Trak Back. The device allows users to control EndoSonics’ intravascular ultrasound (IVUS) imaging catheters, thus facilitating both 3-D-like images and cross-sectional displays. Trak Back was designed for use with EndoSonics’s Oracle ultrasound systems and Visions Five-64 series of ultrasound catheters.

The device is automated, which the Rancho Cordova, CA, company believes will make it easier to use than competitive IVUS products that are mechanical. Trak Back is part of EndoSonics’s strategy to provide its customers with IVUS-guided stenting products by combining its catheters with therapeutic devices. EndoSonics expects to begin shipping Trak Back by the end of the third quarter 1999.