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BSD-2000 PMA

This article was originally published in The Gray Sheet

Executive Summary

BSD Medical submits premarket approval application for tumor hyperthermia therapy May 22. The PMA is based on data from approximately 4,000 treatments of more than 800 patients (1"The Gray Sheet" Jan. 19, 2006, p. 15). The device employs an array of radiofrequency antennae to generate enough energy to target and kill cancer cells...

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High-risk soft tissue sarcoma patients treated with BSD Medical's BSD-2000 hyperthermia system in addition to chemotherapy had nearly double the median time of disease free-survival (31.7 months) and local progression-free survival (45.3 months) compared with those only receiving chemotherapy, according to study results presented June 4 at the American Society of Clinical Oncology conference in Chicago. The 340-patient randomized trial was based on the belief that precision-focused, mild heating of cancer improves blood flow and leads to better absorption of chemotherapy drugs, in addition to directly killing cancer cells and improving chemical reactions of some drugs. BSD Medical submitted a PMA application for the BSD-2000 in May 2006 (1"The Gray Sheet" May 29, 2006, In Brief)...

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