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Medical Devices / Regulatory Affairs / Submissions and Approvals

Varian’s ProBeam Proton Therapy System Gets 510(k) Clearance

Jan. 16, 2014
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Varian Medical Systems’ ProBeam proton therapy radiation treatment system has cleared the FDA’s 510(k) premarket process and is being installed at a U.S. site. The Palo Alto, Calif., company expects the unit to be up and running in the near future.

Varian also has contracts to install ProBeam in Russia and Saudi Arabia.

According to Varian, the physician utilizes a CT scan of the tumor and surrounding anatomy to design a treatment plan. The apparatus is them moved around the patient, delivering a proton beam that targets the tumor without radiating healthy tissue. A scanning beam allows the radiation beam to mirror the shape of the tumor, eliminating the need to manually insert shaping accessories for each beam angle.

In standard X-ray radiation treatment, the beam, which is based on electrons rather than protons, cuts all the way through the patient, creating entry and exit points, said Varian spokesman Spencer Sias. With ProBeam, there is no exit point, which means that surrounding tissue is not dosed with radiation. “Protons are denser, so the proton penetrates to the depth of the tumor and you end up sparing healthy tissue, Sias said. — Lena Freund

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