It’s been the Society for Interventional Radiology meeting in San Diego this week and one highlight has been results of the Coiling vs. Surefire Infusion System in Y90 (COSY) clinical trial. Surefire Medical, Inc. has announced that the study showed significant reductions in fluoroscopy time, procedure time, radiation dose and contrast dose when using the technologically advanced Surefire Infusion System without placing permanent coils.
Selective Internal Radiation Therapy (SIRT) is a direct-to-tumor minimally invasive radiation therapy generally used to treat selected patients with primary or secondary liver tumors. SIRT is pitched as an alternative to placement of embolic coils as a means of protecting healthy tissue from metastasising tumors.
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.
In the randomized, prospective study, which was statistically designed with an ample sample size of 30, half of the patients had permanent embolic coils placed in blood vessels. 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. Furthermore, 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.
“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.
Source: Surefire Medical, Inc., PR Newswire