Sumitomo receives FDA 510(k) clearance for Proton Therapy System

Nov 29 2013

Sumitomo Heavy Industries, Ltd. (TOKYO:6302) announced today that it had received US FDA 510(k) clearance of its Proton Therapy System. It is the first 510(k) cleared medical device for Sumitomo. Proton therapy is a form of radiation therapy, which employs proton beams to kill cancer cells with better dose distribution in comparison with conventional x-rays. Currently 12 facilities are operational and several more are under construction in the United States, and the U.S. proton therapy market is expected to expand in the future.

Proton beam has a unique characteristic called the "Bragg Peak". More absorption dose is delivered as the proton loses its energy; consequently, the maximum dose is deposited just before the beam stops, and there is no radiation dose to normal cells behind the target tumor volume. This unique characteristic is especially advantageous for cancers around critical organ structures and pediatric cancers.

Sumitomo is one of the first proton system suppliers in the world, and it delivered its first commercial system in 1997 to the National Cancer Center Hospital East, Kashiwa, Japan. New projects are now under way in Taiwan, Korea, and Japan. The System has a 230MeV proton accelerator (cyclotron) and 360 degree single or multiple rotating gantries with a proven and robust design.

"With 510(k) clearance, we have received a ticket for admission to the U.S. market, but this is just the beginning of establishing a long term trusting relationship with the equipment users such as hospitals, doctors and cancer patients. The Sumitomo Proton Therapy System has an excellent track record and keeps evolving in performance, function, and reliability with solid technological experiences. We are hoping the Sumitomo Proton Therapy System will be used to save many cancer patients in the U.S.," said Yukio Kumata, Vice President of Sumitomo Heavy Industries, Ltd.