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FDA Approves New Medical Device for Form of Brain Cancer
Date:4/15/2011

ecurrent GBM or with GBM that hadn't responded to traditional therapy. Patients in the study were randomly assigned to receive either the NovoTTF-100A System or chemotherapy treatment.  

The study showed comparable overall survival rates between patients treated with the NovoTTF-100A System and those who underwent chemotherapy.

Patients treated with the NovoTTF-100A System experienced a slightly higher incidence of neurological side effects including convulsions and headaches compared to patients receiving chemotherapy. However, they did not experience the significant side effects associated with chemotherapy, including nausea, anemia, fatigue and serious infections.  

A survey of patients in the study suggested an improved quality of life in the NovoTTF-100A recurrent GBM patients compared to patients receiving chemotherapy.

Patients should not use the NovoTTF-100A System if they have an implanted medical device or a skull defect, or have a known sensitivity to conductive hydrogels, such as those used with electrocardiograms. The NovoTTF-100A System is not intended to be used in combination with other cancer treatment. The device should only be used after other treatments have failed.

The NovoTTF-100A System is made by Novocure of Portsmouth, N.H.

For more information:

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

FDA: Device Approvals and Clearances

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

NCI: What You Need to Know About – Brain Tumors

http://www.cancer.gov/cancertopics/wyntk/brain

The FDA, an agency within the U.S. Department of Health and
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SOURCE U.S. Food and Drug Administration
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