The regulator approved the company's premarket approval (PMA) supplement application for the lighter tumor treating fields (TTFields) delivery system.
The new model incorporates a TTFields generator that is less than half the weight and size of the first generation system.
Novocure used novel digital signal generation technology to reduce the size and weight of Optune.
The first generation Optune system weighs 6 pounds, while the weight of the new system is just 2.7 pounds.
Some of the features of the second generation system include easy-grip texture that enables better handling and a battery indicator which displays power and alerts patients in case of battery change.
A light-detecting sensor will auto-dim the device and charger in the dark; and a no-stop swap feature will allow patients to change batteries or power source without disturbing delivery of TTFields therapy.
Novocure CEO Asaf Danziger said: “We believe the improvements incorporated into the second generation Optune system will make a big difference to the patients and families who face this devastating disease every day.”
The Optune system is intended to treat adult patients aged 22 years or older with histologically-confirmed GBM.
Optune with temozolomide is indicated to treat adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
Last October, Novocure received CE mark approval for the second generation Optune system to market in the European Union and Switzerland.
Image: Novocure’s second generation Optune system. Photo: courtesy of Business Wire.
