FDA Approves New Medical Device for Form of Brain Cancer
SILVER SPRING, Md., April 15, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration recently approved the NovoTTF-100A System, a new device to treat adults with glioblastoma multiforme (GBM) that recurs or progresses after receiving chemotherapy and radiation therapy.
Brain tumors are the growth of abnormal cells in the brain tissue. According to the National Cancer Institute, each year about 19,000 people in the United States are diagnosed with primary brain cancers. In 2010, there were 13,140 deaths from brain and other nervous system cancers in the United States.
GBM is the most common primary brain cancer. The brain tumor is highly resistant to standard treatments such as surgery, radiation and chemotherapy.
When using the NovoTTF-100A System, a health care professional places electrodes on the surface of the patient's scalp to deliver low-intensity, changing electrical fields called "tumor treatment fields" (TTFs) to the tumor site. The unique shape and electrical characteristics of dividing tumor cells make them susceptible to damage when exposed to TTF, which could stop tumor growth.
The device is portable and can be powered with batteries or plugged into an electrical outlet. Patients can use the device at home, allowing them to continue their normal daily activities.
"Recurrent glioblastoma multiforme is a devastating form of brain cancer that often eludes standard treatments," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "The agency's approval of the NovoTTF-100A System shows FDA's commitment to innovative new devices that provide patients with other treatment options."
The FDA based its approval of the NovoTTF 100A System on results from a single international clinical study in 237 patients with r