Conventional endometrial ablation, commonly referred to as "rollerball" ablation used to treat menorrhagia, often entails pretreatment by loop resection, but can be performed without resection, according to the FDA. Novacept initially had indicated that ablation with its NovaSure was faster than rollerball ablation because it did not require resection(1"The Gray Sheet" Oct. 15, 2001, p. 6). However, the 90-second average treatment time demonstrated in the 265-patient trial of the NovaSure is shorter than rollerball ablation with or without resection, according to the agency. Also, the FDA's internal standard for endometrial ablation devices requires that their success rate cannot be 20 percentage points worse than that of the control with a 95% confidence interval, not 80% as successful, as was reported. In the trial submitted in February, the NovaSure slightly exceeded the success rate of the control, but the difference was not statistically significant. Novacept was required to follow up patients from the original study for three years - the same postmarket requirement agreed to by BEI Medical and Ethicon following approval of the Hydro ThermAblator and ThermaChoice, respectively...
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