March 26, 2014—San Diego, CA—Surefire Medical, Inc. today announced that the Coiling vs. Surefire Infusion System in Y90 (COSY) clinical trial, presented today at the Society for Interventional Radiology meeting in San Diego (SIR), showed significant reductions in fluoroscopy time, procedure time, radiation dose and contrast dose when using the technologically advanced Surefire Infusion System without coiling.
The randomized prospective study investigated the feasibility and benefits of performing Selective Internal Radiation Therapy (SIRT) planning without the need to place permanent coils.
“We were able to dramatically reduce all of the primary endpoints, most importantly procedure time (by >50 percent) and radiation dose (by 50 percent) to both patient and operator,” stated Aaron Fischman, M.D., Principal Investigator and Assistant Professor of Radiology and Surgery at the Icahn School of Medicine at Mount Sinai in New York City.
“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,” added Fischman.
In addition to cutting procedure and radiation exposure time by half, fluoroscopic time was reduced by 70 percent, and contrast dose by 50 percent when using the Surefire Infusion System for radioembolization planning.
SIRT is a direct-to-tumor minimally invasive radiation therapy 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 the statistically defined endpoints.
The Surefire Infusion System is a first-in-class medical device with a unique expandable tip 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.
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