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FDA Clears Conforma 3000 Proton Cancer Technology
FDA Clears Conforma 3000 Proton Cancer Technology
WASHINGTON (Reuters Health) - The US Food and Drug
Administration (FDA) has 510(k) cleared Conforma 3000, Optivus
Technology's proton beam anti-cancer therapy.
Studies of 643 patients with prostate cancer treated with protons
showed an overall 5-year post-treatment disease-free survival rate of
89%, according to data published in the fall issue of the International
Journal of Radiation Oncology.
Another study of patients with wet type age-related macular
degeneration demonstrated 18 months of post-treatment disease control
in 89% of patients. Other data suggest that proton therapy results in
87% local tumor control in lung cancer patients over the 50% control
rate achieved through traditional radiation.
Protons deliver homogeneous radiation to irregular three-dimensional
volumes, standard to various cancers, brain tumors and macular
degeneration. Intended as an alternative to surgery and other forms of
radiation, proton therapy is target-specific, delivers more radiation to the
tumor, does not damage normal tissue and has minimal side effects.
Approval of the Conforma 3000 system was more than 5 years in the
making, according to Loma Linda University Medical Center
(LLUMC), in Los Angeles. The center is currently the world's only
operational hospital-based proton therapy site and has treated more than
5,000 patients since 1990.
LLUMC obtained initial FDA approval of the proton technology in
1988 and Optivus' system ``is an upgraded version of that,'' Dennis
Valencia, the firm's vice president of sales and business development,
told Reuters Health.
Thus far, the facility has performed more than 100,000 patient treatment
sessions for conditions including age-related macular degeneration, and
prostate, lung and pediatric cancers.
Medicare and other third-party insurance routinely cover proton
therapy, the company noted.
Optivus, based in San Bernardino, California, estimated that the
potential market for proton facilities will be between 15 and 25 centers
over the next decade, with an equal or greater market abroad.
While there are already 20 proton therapy research sites abroad,
Europe, Japan, Taiwan and China have all expressed interest in
developing hospital-based treatment centers, Valencia noted.
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