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U.S. Department of Health and Human Services

Advisory Committees

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Gastroenterology and Urology Devices Panel Meeting - June 25, 2008

On June 25, 2008, the Gastroenterology and Urology Devices Advisory Panel met to discuss, make recommendations, and vote on a premarket approval application, sponsored by Medical Enterprises, Ltd., for a drug/device combination product designed to prevent recurrence of bladder cancer. Synergo SB-TS 101.1 Device with Mitomycin C is indicated for use for prophylactic treatment of recurrence in patients following endoscopic removal of Ta-T1 and G1-3 superficial transitional cell carcinoma of the bladder (STCCB). Ta-T1 refers to the stage of the tumor, which is a measure of how deep the tumor penetrates into the bladder wall, with Ta and T1 being the most superficial stages for raised bladder tumors. G1-3 refers to the tumor grade, which is a measure of how aggressive the tumor is likely to grow, with G1 being the least aggressive, and G3 the most aggressive. Synergo with Mitomycin C treatment is therefore clinically indicated for STCCB patients of intermediate and high risk.

The panel members voted unanimously to approve with conditions. The conditions are:

  1. The indications for use statement should be amended to state that patients with low risk bladder cancer (Ta, Grade 1, <3 cm, single tumors) should not be treated;
  2. Mandated training should be developed and implemented for clinician users;
  3. A post-approval study as presented by the sponsor should be performed to focus on adverse events in United States subjects for one year; and
  4. The patient guide labeling must be provided to all users.

Contact: Jeffrey Cooper, DVM; Executive Secretary; jeffrey.cooper@fda.hhs.gov

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Transcripts or Executive Summaries may be purchased from:
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