NATICK, Mass., Jan. 31, 2011 /PRNewswire/ — Boston Scientific
Corporation (NYSE:
BSX) today announced that the U.S. Food and Drug Administration
(FDA) has approved 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 will primarily be used by interventional
radiologists for minimally invasive procedures to treat uterine
fibroids and liver cancer. The Company said it plans to
launch the product immediately in the United States.
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.”
The Renegade HI-FLO Fathom Pre-Loaded System complements Boston
Scientific’s extensive portfolio of minimally invasive access and
embolization products to provide physicians with a range of
diagnostic and treatment options for uterine fibroids, liver cancer
and other conditions requirin
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