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Surefire Medical presents COSY clinical trial results

Surefire Medical has announced that the Coiling vs. Surefire infusion system in Y90 (COSY) clinical trial, presented 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.

Mount Sinai in New York City Icahn School of Medicine Assistant Professor of Radiology and Surgery and principal investigator Dr Aaron Fischman noted that they 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.

"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," Dr Fischman added.

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.

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.