Synergo up for approval in the USA!

15 years 8 months ago #18598 by Patricia
Replied by Patricia on topic Synergo up for approval in the USA!
I checked but i didn't see any clinical trials posted yet in the US...any ideas when that might happen Wendy? Pat

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15 years 8 months ago #18586 by slabman
Replied by slabman on topic Synergo up for approval in the USA!
WOW! Sounds like we just need to hang in there 'till this process becomes clinically available and maybe some of us :cheer: can avoid that dreaded bladder removal. :cheer:

Bob
T1 G3
Age 66
DX April 2008
TURB April 2008
Last BCG (#15) April 2009

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15 years 9 months ago #18525 by wendy
FDA s Gastroenterology and Urology Devices Panel unanimously recommended approval of Medical Enterprises Synergo combination product for prevention of bladder cancer recurrence. Conditions of approval include a one-year post-approval study to further assess its safety in the US population, development of labeling specifically stating that the device should not be used in patients with low-risk disease, a physician training program, and distribution of patient guides with the device. (Health News Daily)


More info on this treatment which uses Mitomycin and hyperthermia, and is approved in Europe since '05:
blcwebcafe.org/content/view/106/116/lang,english/

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