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Surefire Medical gets FDA 510(k) and CE Mark approvals for redesigned line of guiding catheters

Surefire Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) and CE Mark approval in Europe for its new line of catheters that include Axis, Cobra1 and Simmons1, used in radioembolization and chemoembolization procedures.

According to Surefire Medical, these catheters are designed to provide interventional radiologists and interventional oncologists with far greater ease in gaining access to patients’ peripheral blood vessels.

Surefire’s newest guiding catheters provide improved trackability, enhanced delivery and optimized torque. These devices feature an ultra soft tip for ease in arterial placement, double-stranded steel braid for optimized torque control and tracking through complex anatomies, multi-segment design for uncompromising support, and lubricious lumen from hub to tip for smooth transitions.

These devices provide three to fourfold reduction in insertion force required for microcatheter delivery, superior kink resistance and dedicated shapes specific to abdominal vasculature.

Surefire Medical CEO Jim Chomas noted the company’s redesigned line of guiding catheters create smooth, superior pathways through which diagnostic and therapeutic devices can selectively access the peripheral vasculature.

"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," Chomas added.

The new guiding catheters will be on display at the Society of Interventional Radiology (SIR) meeting March 22-27. Surefire Medical is accepting pre-orders for the redesigned line of guiding catheters for April 2014 delivery.