January 12, 2012 -- The U.S. Food and Drug Administration (FDA) recently cleared a hyperthermia system designed to warm cervical cancer tumors so they respond better to radiation therapy treatments.
The BSD Medical BSD-2000 Hyperthermia System delivers focused therapeutic heating (hyperthermia) with temperatures greater than 104 degrees Fahrenheit, to cancerous tumors by applying radiofrequency (RF) energy. The energy is delivered in the frequency range of 75 to 120 MHz. The BSD-2000 delivers RF energy to a patient using a power source and an array of antennae that surround the patient’s body. The energy can be electronically focused to produce a localized electromagnetic power field. This can be adjusted to target the three-dimensional shape, size and location of the tumor, providing dynamic control of the heat delivered to the tumor region. This method of therapeutic heating utilizes the adjustment of frequency, phase, and amplitude from multiple power sources, along with an applicator selection and patient positioning, to optimize heating of the targeted body tissues.
The system is indicated for use in conjunction with radiation therapy for the treatment of cervical cancer patients who are ineligible for chemotherapy. The FDA said it increases the response of tumor cells to radiation therapy.
The FDA said the system should not be used in patients who have:
- medical devices that are implanted, carried or worn on their bodies
- severe dysfunction of the heart or lungs
- electrically conductive, metal, or foreign objects in, on or attached to their body
- severe high or low blood pressure
- severe cerebrovascular disease, or
- when the treating physician cannot place either a temperature sensor into the tumor or into a body cavity.
For a summary of safety and probable benefit (SSPB) and product labeling, visit www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=h090002