Home › Forums › All Categories › Non Invasive Bladder Cancer › Synergo up for approval in the USA!

  • Non Invasive Bladder Cancer

    Synergo up for approval in the USA!

    Posted by wendy on June 28, 2008 at 8:19 am

    Start of Discussion
    0 of 0 replies June 2018
    Now

    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:
    http://blcwebcafe.org/content/view/106/116/lang,english/

    replied 16 years ago 3 Members · 2 Replies
  • 2 Replies

  • Guest
    June 30, 2008 at 4:10 am

    I checked but i didn’t see any clinical trials posted yet in the US…any ideas when that might happen Wendy? Pat

  • Slabman

    Member
    June 29, 2008 at 10:03 pm

    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

Log in to reply.