McLaren’s proton therapy system gets FDA clearance

FLINT — Innovative therapy treatment for cancer patients has moved closer to becoming a reality with clearance last week of a system under development at McLaren’s Proton Therapy Center on Beecher Road.

ProTom International, Inc, the Texas-based developer and manufacturer of the technologically advanced proton beam radiation therapy system, announced on March 21 that it has received 510(k) clearance from the FDA for its Radiance 330 Proton Therapy System.

“The receipt of 501(k) clearance is the final culmination of a thorough and rigorous FDA review of the safety and effectiveness of the Radiance 330,’’ Steve Spotts, chief executive officer and co-founder of ProTom International, said in a press release.

“This achievement accelerates our team’s single and relentless mission to place this highly sophisticated and targeted cancer-fighting tool within reach of many more physicians. Our team could not be more proud of reaching this milestone and will continue our work to advance the delivery of proton therapy while driving down the cost of this much-needed technol- ogy,” he said.

McLaren’s Proton Therapy Center is a partnership between McLaren Health Care and ProTom International. McLaren is the first site in the world to incorporate the Radiance 330 treatment in its delivery of proton therapy. It also will be the only center of its kind in Michigan when it opens.

The Radiance 330 is a compact, modular and more affordable proton beam delivery system. It delivers extremely focused, conformal, scanned proton beams that destroy tumors while sparing nearby healthy tissue and anatomical structures, according to information on the center’s web site.

The FDA clearance was hailed as “a very important step leading to first patient treatment,’ in a public relations statement on Tuesday from McLaren.

“Teams of medical physicists and equipment specialists are now conducting acceptance testing and embarking on commissioning to assure the utmost in patient safety and treatment,” the statement said.

“The timeframe involved to develop and implement a project of this magnitude and complexity historically has been a minimum of five years from contract execution. The McLaren Proton Therapy Center is running well ahead of this timeframe. At this time, no set date has been established.

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