Combined Treatment of Patients With Newly Diagnosed Glioblastoma Using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System for Intraoperative Balloon Electronic Brachytherapy

The Elekta Xoft® Axxent® Electronic Brachytherapy (eBx®) System is a device that delivers high-dose-rate radiation. It is designed for use with Axxent applicators to treat neoplastic tumors inside or on the body surface where radiation therapy is indicated. The Axxent System and its applicators were cleared by the FDA under 510(k) submissions K050843, K072683, K090914, and K122951. The Russian Federation medical device registration certificate (No. RZN 2015/2593) was obtained on April 17, 2015.