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CIVCO Medical obtains FDA 510(k) clearance for EX3 stepper

CIVCO Medical Solutions, a medical technology company, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its EX3 stepper, which is used while performing real time planning for low dose rate (LDR) or high dose rate (HDR) ultrasound-guided brachytherapy for prostate cancer detection and treatment.

In LDR prostate brachytherapy, tiny radioactive particles are permanently implanted into or near the tumor with the help of a needle for treatment. This brachytherapy involves internal radiotherapy.

HDR temporary brachytherapy involves placing of a tiny radioactive source directly into the tumor or near the targeted treatment area.

The EX3 Stepper reports angular and linear position directly to the treatment planning software offering timely analysis.

The system offers rapid connection for data analysis and reduces clutter in the surgical suite through direct communication.

It features a removable electronic unit that mitigates risk of transmission component damage and reduces cleaning time after the procedure.

The EX3 stepper is compatible with BK Medical, GE Healthcare, Hitachi Aloka and Siemens transrectal ultrasound probes. Currently, it is validated for use with Varian Vitesse and VariSeed treatment planning software.

EX3 stepper has also obtained CE Mark approval for sale in the EU and other countries where the CE Mark is recognized.