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Hyperthermia Therapy Work? Therapy Right for You? Using Focused Microwave Energy, the Tumor Is Heated to Approximately 108°F

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Hyperthermia Therapy Work? Therapy Right for You? Using Focused Microwave Energy, the Tumor Is Heated to Approximately 108°F INDICATIONS FOR USE In patients with severely compromised pain The BSD-500 Hyperthermia System has been response, monitor closely other physiological approved by the FDA for use alone or in conjunc- indicators of excessive heat delivery. tion with radiation therapy in the palliative man- Monitor closely patients with metallic implants agement of certain solid surface and subsurface (joint prostheses, dental braces, etc.) during malignant tumors (i.e., melanoma, squamous- or treatment because such metal objects may be basal-cell carcinoma, adenocarcinoma, or sar- excessively (and preferentially) heated. coma) that are progressive or recurrent despite conventional therapy. ADVERSE REACTIONS CONTRAINDICATIONS SIDE EFFECTS Although hyperthermia has the potential for producing a variety of adverse Because the patient’s ability to detect pain is an effects, those actually observed have been essential safety mechanism, hyperthermia is limited to direct effects of heating upon tissue contraindicated in patients whose pain response and indirect effects related to tumor necrosis. has been significantly decreased by any means Statistical analysis of clinical data obtained in (previous surgery or ionizing radiation therapy, re- BSD Medical’s studies has provided the following gional or general anesthetic, or other condition). approximate figures for hyperthermia in general: Since excessive heating of normal tissue is Burns. Patients have experienced in 9.7% of prevented by normal blood perfusion, it is tumor sites studied, surface burns and blistering imperative that adequate circulation be present in the area of the delivery of therapeutic heat and maintained in all tissues within the heating by local microwave applicators of the BSD-500 field. Treatment with the BSD-500 Hyperthermia Hyperthermia System. Adherence to recom- System is contraindicated in patients having mended applicator placement techniques and known decrease in circulation in the heated area bolusing practices greatly reduces the number produced by any means (i.e., vasoconstrictive of incidents. drugs, DIC, ischemia or other cause). Pain. Patients have experienced, in 8.4% of Because electromagnetic radiation from the tumor sites studied, localized and temporary pain applicators of the BSD-500 Hyperthermia System in the area of, and during delivery of, therapeutic may interfere with the operation of an electronic heat by local microwave applicators of the BSD- device, hyperthermia treatments are contraindi- 500 Hyperthermia System. The use of surface cated in patients with cardiac pacemakers. cooling techniques can diminish this pain. RESTRICTIONS Ulceration. Patients have experienced, in 3.6% The sale, distribution, and use of the BSD-500 of tumor sites studied, ulceration from rapid tumor Hyperthermia System are restricted to prescrip- necrosis following successful hyperthermia treat- tion use. ment with the BSD-500 Hyperthermia System. Such ulceration may produce both fever through The BSD-500 Hyperthermia System is to be used toxemia and patient discomfort through drainage only by qualified operators upon the prescription and bleeding. and under the supervision of a physician who is experienced in clinical hyperthermia. Infection. Patients have experienced, in 1.8% of tumor sites studied, local and systematic WARNINGS infections resulting from the placement of the Hyperthermia treatment can be safely and temperature probes of the BSD-500 Hyperther- effectively administered only after careful place- mia System and from the ulceration related to ment of temperature probes as described in the rapid tumor necrosis. These infections have Reference Manual and with alert monitoring of generally been local. tissue temperatures during treatment. POTENTIAL ADVERSE HEALTH EFFECTS OF Hyperthermia treatment presents a potential safe- THE DEVICE ABOUT BSD MEDICAL ty hazard in patients whose pain response has Hyperthermia has the potential for producing been decreased because of disease, previous the conditions listed below, as a result of the BSD Medical develops, manufactures, surgery, ionizing radiation therapy, chemotherapy, delivery of therapeutic heat or of exposure to or general or regional anesthesia. electromagnetic radiation. However, none of markets and services systems to treat The electromagnetic energy from microwave these adverse reactions was observed during the cancer and benign diseases using heat applicators may interfere with the operation of the clinical investigation of local hyperthermia. cardiac pacemakers or other implanted electronic Cataracts. Inadvertent heating of the eye may therapy via focused radio frequencies devices. occur during treatment of tumors in the head or and microwave energy. Large thermal doses (a continued elevation of neck. A single high dose of microwave radiation moderately high temperature or a short extreme or repeated exposure over a long period of time elevation of temperature) in normal tissues may result in cataract formation which may not be situated in the vicinity of the treated tumor or observable for several weeks. between the tumor and the body surface may Male Sterility. A single high dose of microwave result in regions of thermal aseptic necrosis that radiation to the testes, or testicular heating for a require medical intervention and that may not be prolonged period of time, may result in temporary apparent on inspection of the skin. or permanent sterility. Treatment of tumors located in the neck and head Exacerbation of pre-existing disease. Patients may cause inadvertent heating of thermoregula- having borderline cardiopulmonary function sec- tory centers located in the brain stem and induce ondary to coronary atherosclerosis, emphysema, general thermoregulatory response exceeding or other conditions, may not be able to tolerate the patient’s compensatory capabilities. the additional systematic stress of extensive or PRECAUTIONS prolonged hyperthermia. Adhere to recommended procedures for Enhanced drug activity. Elevated temperatures temperature probe placement and selection may be expected to affect the pharmacologic of control probe to minimize the probability of activity of some drugs, with unpredictable results. excessive temperature in normal tissue or of Altered vascular perfusion may dramatically Hyperthermia inadequate temperature in the tumor. Observe affect the local tissue effects of systemic or BSD MEDICAL CORPORATION strict adherence to aseptic techniques during infused drugs. the invasive placement of catheters to avoid 2188 West 2200 South localized infections, and instruct patients in the Thermal Stress. Significantly increasing the Salt Lake City, UT 84119-1326 USA Therapy daily care of indwelling catheters and probe sites core temperature of the body or overheating PH 1-866-690-HEAT (4328) to prevent sepsis. the thermo-regulatory center in the brain my result in thermal stress exceeding the patient’s FX 801-972-5930 To ensure accurate temperature monitoring dur- compensatory mechanisms. Reliable prediction ing treatments, verify calibration of temperature of the consequences of thermal stress in patients [email protected] Information For probes daily or as used. with cardiovascular impairment is not possible. www.TreatWithHeat.com Adhere to recommended applicator placement Signs of consequences of thermal shock or of local brain overheating may appear after several Cancer Patients and bolusing practices to reduce the likelihood of surface burns and blistering from the subsequent (up to 24) hours. delivery of therapeutic heat. Is Hyperthermia How Does Hyperthermia Therapy Work? Therapy Right for You? Using focused microwave energy, the tumor is heated to approximately 108°F. Performed What is Hyperthermia? superficially or via interstitial probes, heat can damage cancer cells at levels that are usually safe Hyperthermia is a therapy used to heat tumors. for normal cells, and can be used to attack cancer Research has shown that heat can damage in four major ways: cancer cells while also increasing the effect of radiation therapy in treating some tumors that First, heat damages or weakens the cells of are recurrent or progressive despite conventional the tumor. Second, heat increases blood flow therapy. through the weakened tumor, which can allow radiation therapies to permeate the tumor, not While it has been known for hundreds of years Clinical studies using BSD’s hyperthermia just attack it from the outside. Third, increased that fevers can kill cancer cells, only recently has systems in conjunction with radiation therapy blood flow raises oxygen levels in tumors so technology been developed that can control and have shown that 83.7% of that the cancer can be more effectively treated focus heat specifically on tumors. Hyperthermia patients had some tumor by radiation therapy. Fourth, when the body treatments are typically given in Radiation regression (reduction), senses fever it can stimulate the natural immune Oncology departments several 37.4% of patients had system. For these reasons, hyperthermia is times a week either before or after a complete tumor usually used in combination with radiation radiation therapy. Each treatment regression and 24.5% therapy. session lasts for approximately one had a greater than 50% hour. tumor regression. The primary types of tumors included in Recurrent Cancer this study were recurrent chest wall Management Using cancer, recurrent head and neck cancer, Hyperthermia recurrent melanoma, and recurrent The BSD-500 Hyperthermia sarcoma. System has been
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