FDA Approves Boston Scientific's Renegade Hi-Flo Fathom Preloaded System

January 31, 2011—Boston Scientific Corporation (Natick, MA) announced that the US Food and Drug Administration (FDA) has approved its Renegade Hi-Flo Fathom preloaded system for selective access and delivery of diagnostic, embolic, and therapeutic materials into the peripheral vasculature. The system, which will primarily be used for minimally invasive procedures to treat uterine fibroids and liver cancer, is being launched immediately in the United States, the company stated.

According to Boston Scientific, the Renegade Hi-Flo Fathom system combines the torque response, flexibility, and high visibility of the Fathom-16 steerable guidewire with the performance of the Renegade Hi-Flo microcatheter, preloaded in a single convenient platform. The system will be available in eight configurations to suit a broad range of peripheral embolization procedures.

“The excellent deliverability, torque transmission, and flow capacity of the Renegade Hi-Flo Fathom preloaded system provides physicians with the performance they need to efficiently access tortuous vessels across many types of interventional oncology procedures,” commented Jeff Geschwind, MD. “Having the Fathom-16 guidewire preloaded in the Renegade Hi-Flo microcatheter will reduce my procedural preparation time and the number of devices that my staff must manage.”