Terumo Corp. (TYO:4543) subsidiary MicroVention today released results from a study of its HydroCoil embolic system, touting that the trial met its primary and secondary endpoints and showed low adverse composite outcomes.
The 513-patient prospective, randomized, controlled trial aimed to explore the use of the HydroCoil embolic system for treating endovascular aneurysms compared to bare platinum coils, the Tustin, Calif.-based company said.
“The results of the Great randomized trial demonstrate the efficacy of aneurysm treatment using our hydrogel coils and are aligned with the results of other clinical studies on this technology,” prez & CEO Richard Cappetta said in a press release.
In the trial, the primary endpoint was a composite of major aneurysm recurrence at 18 months, retreatment at 18 months, morbidity which would prevent angiographic follow-up and all-cause death. Trial investigators used at least 50% hydrogel coils by length compared against treatments using 100% bare platinum coils.
“Aneurysm treatment technology is evolving quickly. It is important to understand the safety and efficacy of new devices through sound scientific methods. I was intrigued by the opportunity to test whether MicroVention’s unique hydrogel technology can improve patient outcomes in a wide-range of aneurysms. We are pleased that this independent study showed that hydrogel technology reduces a composite of adverse events, retreatments, morbidity and mortality compared to traditional bare platinum coils,” principal investigator Christian Taschner of Germany’s University of Freiburg said in a prepared statement.
The LightStrike device is designed to use pulsed xenon ultraviolet room disinfection technology to remove pathogens such as C. diff, staphylococcus aureus and carbapenem-resistent Enterobacteriaceae, Terumo said. The Xenex LightStrike device has also been shown to be effective against Ebola and Anthrax, the company added.