November 21, 2013 — Civco Medical Solutions announced that its EX3 Stepper for low-dose rate (LDR) and high-dose rate (HDR) ultrasound-guided
brachytherapy for
prostate cancer detection and
treatment received U.S. Food and Drug Administration (FDA) 510(k) clearance.
The EX3 Stepper’s modular design reports angular and linear position directly to the manufacturer’s treatment planning software intraoperatively. Through direct communication, the stepper offers rapid connection for data analysis and reduces clutter in the surgical suite. The unique design of the EX3 also features a removable electronic unit that mitigates the risk of damaging transmission components and reduces cleaning time after the procedure.
Civco’s EX3 Stepper, like its predecessor the EXII, offers compatibility for BK Medical, GE Healthcare, Hitachi Aloka and Siemens transrectal ultrasound probes, and it is currently validated for use with Varian Vitesse and VariSeed treatment planning software.
The EX3 has also received the CE mark the EX3 for sale in the European Union and other countries that recognize the CE mark.