GammaPod立体定向放疗系统-使用乳癌
总结
FDA澄清立体定向放疗系统在治疗乳癌中使用。
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今天，美国食品和药品监管局澄清一个新无创立体定向放疗系统意向为在乳腺组织中治疗癌症中使用。
FDA的装置和辐射卫生中体外诊断和辐射卫生中心办公室中对辐射卫生代理副主任Robert Ochs，Ph.D.说：“用今天的澄清，患者将已得到一种治疗选择，它提供更大准确性输送辐射治疗至乳癌而保存周围乳腺组织，”
对癌症患者放疗是一种重要治疗。所有癌症患者的约60 %将用放疗的某种形式治疗。在放疗期间，肿瘤细胞被杀死当它们的DNA被正在被吸收至它们的辐射损伤。而辐射治疗有杀死肿瘤细胞的潜能，它也可能损伤肿瘤周围的健康组织。
GammaPod系统是意向在无创立体定向输送辐射剂量至乳腺的一部分(部分体积)与乳腺保护治疗相结合。操作期间，辐射被输送至乳腺的特异性区域。GammaPod未被显示将是与全乳腺放射治疗(WBRT)一样有效和不意向替代WBRT。
GammaPod系统是专门的立体定向放射治疗技术被设计治疗乳腺癌。GammaPod使用来自36个旋转放射活性钴-60放射源聚焦成千的辐射束在与一个两-层，真空-辅助杯结合固定乳房组合实现一个更准确输送辐射。GammaPod设计在治疗时固定乳房提供辐射剂量对乳房，心脏和肺内周围健康组织辐射剂量的最小化的优点获益。
对今天的澄清，FDA审评科学证据包括一项临床研究17患者被测试准确地将处方剂量递送至乳房肿瘤同时使对健康组织的辐射最小化的可行性。临床证据支持输送处方剂量至乳腺肿瘤与最小的辐射-诱发副作用例如皮肤发红或红斑。
GammaPod系统被审评通过上市前通知510(k)途径。一个510(k)是由装置制造商所做一种上市前递交至FDA证实新装置是实质上地等同于一个合法上市所述装置。
FDA授予GammaPod的澄清至Xcision Medical Systems，LLC
Administering an intense, short-duration course of treatment to a small volume in the breast brings a unique set of challenges. Traditional equipment designed for lengthy courses of 3D conformal radiotherapy to large volumes anywhere in the body may not be well suited for this task. That is why Xcision has designed and developed the GammaPod system as a dedicated, no-compromise solution for partial breast irradiation. It doesn’t treat prostate cancer, it doesn’t treat large volumes and it’s not designed for a course of treatment to be drawn out over several weeks. Instead, on each of just 1-5 treatment days, custom-designed software and hardware would be used to plan and deliver an individualized, patient-friendly treatment to a small volume of breast tissue.
One of the key design goals of the GammaPod system is to create a practical, comfortable, means of prone treatment. With the patient lying prone, rather than on her back, the treated breast naturally falls further away from the chest cavity, helping to minimize dose to organs in that region.

The GammaPod™ system is custom-designed for partial breast irradiation with the patient in a prone orientation
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590313.htm