> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Novocure PMA Supplement for 2nd Gen Optune System
- URL: https://www.fdaweb.com/novocure-pma-supplement-for-2nd-gen-optune-system/
- Published: 2016-01-07T12:00:00.000Z
- Updated: 2026-09-15T02:25:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134371

> Novocure has filed a PMA supplement for its second generation Optune system for treating glioblastoma patients. The portable device is designed to deliver “Tumor Treating Fields” (TTFields) therapy to patients with newly diagnosed and recurrent glioblastoma. Novocure says it designed the second generation system to improve the convenience and manageability of TTFields therapy for patients. It features a TTFields generator that is half the size and half the weight of the current system. It weighs 2.7 pounds compared to the current version that weighs 6 pounds.  
>  
>  
>  
> The company says that *in vitro* and *in vivo* studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. “TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death,” it says.  
>  
>  
>  
> In the U.S., Optune is intended as a treatment for adult patients with histologically-confirmed glioblastoma multiforme. Optune with temozolomide is also indicated for treating adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.