Sepracoat data

GENZ said it plans to file a PMA this year based on results from a randomized blinded trial of 362 women undergoing myomectomy and other gynecological surgery.

The trials showed that patients treated with Sepracoat had a statistically significant lower incidence of surgical adhesions than those in the control group. Specifically, treated women had a lower proportion of sites involved, and more women had no adhesions at all at the sites examined. In addition, treated patients had less severe lesions, which also was statistically significant. No adverse effects were noted. ...