Recently, the reporter learned from the Shanghai Institute of higher studies of the Chinese Academy of Sciences that the fixed beam and 180 degree treatment room of the first registration unit of the first domestic proton therapy device completed the clinical trial, and a total of 47 subjects completed the treatment. After the 3-month visit period, the relevant project team of the device will submit materials to the device audit center of the National Health Commission to apply for the medical device registration certificate. This marks the last key step towards the registration and listing of the first domestic proton therapy device, and the clinical application of the domestic proton therapy device is about to begin. The preliminary results showed that among the 47 subjects, some patients achieved complete remission of the tumor at the end of all sub treatments. One patient with chordoma of the skull base began to recover part of his vision after 10 treatments. All patients have no complaints of discomfort at present. During the whole treatment process, the first domestic proton therapy device operated stably and reliably, and all performance indicators met the clinical requirements. The clinical team said that the device had reached the status of formal clinical operation. The relevant person in charge said that after the outbreak, the commissioning and third-party testing of the 360 degree rotating beam treatment room and eye beam treatment room of the device will be carried out in an all-round way, striving to complete the registration testing by the end of the year and prepare for the clinical trial of the second registration unit. The demand for proton therapy devices at home and abroad has increased rapidly in recent years, but this large-scale precision medical device has complex technology, high cost and operation and maintenance cost. The domestic device mainly relies on imports, and the patient treatment cost remains high. In order to realize the localization of proton therapy devices, the first domestic proton therapy demonstration device R & D project was officially approved in 2012. After the project was launched, all participating units made unremitting efforts to make breakthroughs in key technologies such as self-developed compact synchrotron magnetic focusing structure, high saturation strong field magnet, ultra-low ripple magnet power supply, magnetic alloy high-frequency cavity, injection and extraction cutter, precise timing, beam modulation and extraction, rotating frame, point scan therapeutic head, robot therapeutic table, image guidance and respiratory motion management. (outlook new era)
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Source：http://digitalpaper.stdaily.com/
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