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FDA clears Renegade HI-FLO Fathom Pre-Loaded System

Boston Scientific has received the US Food and Drug Administration (FDA) approval for its Renegade HI-FLO Fathom Pre-Loaded System for selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature.

The system is designed to be used for minimally invasive procedures by interventional radiologists to treat uterine fibroids and liver cancer.

The Renegade HI-FLO Fathom Pre-Loaded System combines the turn-for-turn torque response, flexibility and high visibility of the Fathom-16 Steerable Guidewire with the Renegade HI-FLO Microcatheter, pre-loaded in a single convenient platform.

Boston Scientific said the system will be available in eight configurations to suit a broad range of peripheral embolization procedures.

Boston Scientific Endovascular Unit senior vice president and president Joe Fitzgerald said adding the pre-loaded system to their product offerings demonstrates Boston Scientific’s commitment to provide a comprehensive suite of less-invasive solutions for interventional radiologists and their patients.

"We will continue to bring additional technologies to market that advance the various therapies performed by specialists in vascular and interventional radiology," Fitzgerald said.