Surefire Medical Receives FDA Clearance for Next Generation Infusion System

New catheter system’s infusion efficiency exceeds 99 percent; designed to significantly reduce backflow

WESTMINSTER, Colo., USA (June 21, 2012) – Surefire Medical Inc. announced today that it has received 510(k) FDA clearance to market the Surefire Infusion System ST/LT, the next generation of the company’s novel infusion technology.  The Surefire system is designed to deliver therapy with higher infusion efficiency than conventional microcatheters.

The Surefire Infusion System’s unique expandable tip dynamically expands in reverse flow and collapses in forward flow.

Pre-clinical study results presented at the World Congress of Interventional Oncology (WCIO) in June 2011 found that the Surefire Infusion System achieved an average infusion efficiency of 99.1 % compared to 72.8% with a standard infusion catheter.

In addition, an abstract presented by John Louie, M.D. of Stanford University during the 2012 Annual Scientific Meeting for Society of Interventional Radiology (SIR) stated, “In chemoembolization patients, completion C-arm CT imaging suggested a pattern of increased microsphere tumor penetration and contrast retention. In short term follow-up, no clinical evidence of non-target embolization was observed.”

“Working with key interventional radiologists, our research and development team has created a highly trackable, sleek microcatheter designed to accommodate smaller vessels and selective procedures,” said Jim Chomas, CEO of Surefire Medical. “The addition of the new Surefire Infusion System ST/LT will enable physicians to treat more patients with addressable disease.”

Since launching in August 2011, the initial Surefire Infusion System has been used in 68 high-volume, top-tier hospitals, primarily in interventional procedures to treat primary and secondary liver cancer.

 

Achievement

Clinical Data Shows Surefire Technology Achieved 79% Objective Response versus 37% Using a Standard Microcatheter in Treating Primary Liver Cancer. Study presented at SIR 2017 Annual Scientific Meeting.