This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: BSD-2000 Hyperthermia System
PMA Applicant: BSD Medical Corporation
Address: 2188 West 2200 South, Salt Lake City, UT 84119, USA
Approval Date: November 18, 2011
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf9/h090002a.pdf
What is it? BSD-2000 Hyperthermia System is intended to be used in cervical cancer treatment.
How does it work? The BSD-2000 Hyperthermia System is intended to deliver focused therapeutic heating (hyperthermia); with temperatures greater than 104º Fahrenheit (40º Celsius), to cancerous tumors by applying radiofrequency (RF) energy at the frequency range of 75 to 120 MHz. (The term RF energy is a general term that refers to frequencies above audio and below light. The terms radiofrequency [RF], electromagnetic [EM], or microwave [MW] are used interchangeably to refer to this frequency range.) 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 delivered by the BSD-2000 can be electronically focused to produce a localized EM power field. This can be adjusted to target the 3-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.
When is it used? The BSD-2000 Hyperthermia System is indicated for use in conjunction with radiation therapy for the treatment of cervical cancer patients who are ineligible for chemotherapy.
What will it accomplish? The BSD-2000 Hyperthermia System increases the response of tumor cells to radiation therapy.
When should it not be used? This 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.
Additional information: Summary of Safety and Probable Benefit and labeling are available online.