Boston Scientific received FDA regulatory clearance to market the Renegade HI-FLO Fathom Pre-Loaded System for “selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature” mainly during interventional oncology procedures. The Renegade HI-FLO microcathether and Fathom-16 guidewire were previously sold as separate devices, but are now available pre-loaded for quicker turnaround in the cath lab.
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 clinically proven performance of the Renegade HI-FLO Microcatheter, pre-loaded 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 Pre-Loaded System provides physicians with the performance they need to efficiently access tortuous vessels across many types of interventional oncology procedures," said Jeff Geschwind, M.D., Professor of Radiology, Surgery and Oncology, and Director of Vascular and Interventional Radiology at the Johns Hopkins University School of Medicine. "Having the Fathom-16 Guidewire pre-loaded in the Renegade HI-FLO Microcatheter will reduce my procedural preparation time and the number of devices that my staff must manage."
Press release: Boston Scientific Announces FDA Approval of Renegade® HI-FLO™ Fathom® Pre-Loaded System…
Product page: Renegade HI-FLO Microcatheter, Kits and Systems…