Surefire Medical Receives FDA Clearance, CE Mark For New Line Of Guiding Catheters
WESTMINSTER, Colo., March 13, 2014 /PRNewswire/ — Surefire Medical, Inc., developer of a new class of infusion systems designed to maximize direct-to-tumor drug delivery, announced today that the company has received 510(k) FDA clearance and the CE Mark for its enhanced line of Surefire Guiding Catheters used in radioembolization and chemoembolization procedures.
Surefire’s newest guiding catheters–Axis, Cobra1 and Simmons1–are designed to provide Interventional Radiologists and Interventional Oncologists with far greater ease in gaining access to patients’ peripheral blood vessels.
In mapping, therapeutic or combined mapping/drug delivery procedures, improved trackability, enhanced delivery and optimized torque are achieved as a result of:
-- An ultra soft tip for ease in arterial placement -- Double-stranded steel braid for optimized torque control and tracking through complex anatomies -- Three to fourfold reduction in insertion force required for microcatheter delivery -- Multi-segment design for uncompromising support -- Superior kink resistance -- Dedicated shapes specific to abdominal vasculature -- Lubricious lumen from hub to tip for smooth transitions
“Surefire’s redesigned line of guiding catheters create smooth, superior pathways through which diagnostic and therapeutic devices can selectively access the peripheral vasculature,” said Jim Chomas, CEO of Surefire Medical. “We are excited to offer a suite of products, including our novel, technologically advanced Surefire Infusion System, that enable physicians to treat more patients with addressable disease.”
Fewer than 20 percent of the 2.2 million worldwide cases of primary or secondary liver cancers are operable. Many can, however, be treated with chemoembolization or radioembolization, minimally invasive direct-to-target procedures.
Pre-orders are being accepted for April delivery. The new guiding catheters will be on display at the Society of Interventional Radiology (SIR) meeting March 22-27.
About Surefire Medical
Surefire Medical, Inc., based in Westminster, Colo., was founded in 2009 to develop innovative infusion systems for the Interventional Radiology and Interventional Oncology markets. Surefire’s infusion systems are designed to precisely deliver embolic agents through a unique microcatheter with an expandable tip that collapses in forward flow and dynamically expands to the vessel wall in reverse flow in order to maximize targeted delivery, minimize reflux and reduce damage to healthy tissue. The Surefire Infusion System and specialty catheters have received regulatory approval in the U.S., Europe, Canada, Australia, New Zealand and Taiwan. www.surefiremedical.com
SOURCE Surefire Medical, Inc.