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, Hologic said, from 9 – 9.5 days to 4.8 – 5 days, and diminished bleeding after ablation, as reported by sanitary product use, declined for NovaSure and Minerva patients at 78% and 61% respectively.
Menstrual pain post-ablation was lower in the NovaSure group versus the Minerva Group at 21% and 41%, respectively. Improvements in the rate of pre-menstrual syndrome post-ablation was reported among 85% of NovaSure patients, versus 68% of Minerva patients, Hologic said.
Both groups reported improved quality of life due to the lowered impact of menstrual bleeding, with impact scores improved by 0.3 points in NovaSure patients and 0.7 points in the Minerva group.
A total 94% of NovaSure patients reported satisfaction with clinical outcomes, versus 78% of Minerva patients, while 92% of NovaSure patients said they would recommend the procedure to friends, versus 78% of Minerva patients.
NovaSure patients experienced a higher rate of perioperative adverse events, with 10 patients experiencing them versus 5 Minerva patients. A total of five additional gynecologic procedures were performed in four NovaSure patients and four procedures performed in three Minerva subjects, Hologic reported.
Last month, Hologic said it won FDA premarket approval to add Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology to its 3Dimensions breast tomosynthesis machines.