March 25, 2014
Surefire Medical Presents COSY Clinical Trial Results
March 26, 2014—Surefire Medical, Inc. (Westminster, CO) announced that the COSY (Coiling Versus Surefire Infusion System in Y90) clinical trial showed significant reductions in fluoroscopy time, procedure time, radiation dose, and contrast dose when using the Surefire infusion system without coiling. The study data were presented at the Society of Interventional Radiology’s 39th annual scientific meeting being held in San Diego, California.
The Surefire infusion system features an expandable tip that is designed to minimize reflux and maximize direct-to-tumor delivery of cancer-fighting agents. It is used for diagnostic and therapeutic radioembolization or chemoembolization procedures.
According to Surefire Medical, the randomized prospective study investigated the feasibility and benefits of performing selective internal radiation therapy (SIRT) planning without the need to place permanent coils. SIRT is a direct-to-tumor minimally invasive radiation therapy that is generally used to treat selected patients with primary or secondary liver tumors. In the study, which was statistically designed with an ample sample size of 30, half of the patients had permanent embolic coils placed in blood vessels to protect healthy tissue from damage. The other half underwent the procedure using the Surefire infusion system without coiling.
The study evaluated the primary endpoint of fluoroscopic time between Surefire versus a standard microcatheter. Secondary endpoints were procedure time, radiation exposure, and contrast usage. The COSY trial showed that Surefire significantly exceeded all of the statistically defined endpoints.
The COSY study’s Principal Investigator Aaron Fischman, MD, commented in the company’s press release, “We were able to dramatically reduce all of the primary endpoints, most importantly procedure time (by > 50%) and radiation dose (by 50%) to both patient and operator.” Dr. Fischman, who is Assistant Professor of Radiology and Surgery at the Icahn School of Medicine at Mount Sinai in New York City, added, “Use of the Surefire infusion system in the trial was safe, without any minor or major adverse events at 30-day follow-up. This technology has the potential to improve the safety and efficient delivery of SIRT in our liver cancer patients.”
The company noted that in addition to cutting procedure and radiation exposure time by half, fluoroscopic time was reduced by 70% and contrast dose by 50% when using the Surefire infusion system for radioembolization planning.