Hologic touts study comparing NovaSure to Minerva ’ s endometrial ablation device

Hologic (NSDQ:HOLX) yesterday released results from a study comparing its NovaSure endometrial ablation system to Minerva Surgical‘s endometrial ablation device, touting a higher one-year rate of amenorrhea and higher quality of life for women treated with the NovaSure , despite experiencing a higher rate of perioperative adverse events. Results from the trial were published in the International Journal of Women’s Health, Marlborough, Mass.-based Hologic said. In the 189-patient study, researchers compared the use of endometrial ablation with either the NovaSure or Minerva device. The study’s primary efficacy outcome was the percentage of patients experiencing amenorrhea post ablation, with secondary efficacy outcomes including changes in abnormal uterine bleeding symptom severity from baseline, secondary intervention rates for refractory AUB and patient satisfaction. The trial’s primary safety-related outcome was the incidence of perioperative adverse events including pain, fever, nausea, vomiting, vaginal bleeding and vaginosis, among others, Hologic said. Results from the trial indicated a 64% rate of amenorrhea in patients treated with the NovaSure device, higher than the 42% rate reported in patients treated with the Minerva device. Bleeding reduction in women with AUB was comparable between the NovaSure and Minerva system at 97% and 92%, respectively. The mean amount of days per cycle with reported bleeding were comparably reduced in both groups...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Women's Health Source Type: news