NovaSure Procedure Efficacy
The pivotal study supporting FDA approval of the NovaSure system, resulted in 1- year success rates of 77.7% and 1 year amenorrhea rates of 36%. To date, more than 2.5 million procedures have been performed1.
NovaSure Endometrial Ablation in Peer-Review Literature
15 Years of Real World Data in Over 80 Published Studies. The Ten Year Literature review of the Global Endometrial Ablation with NovaSure device examines the peer-reviewed literature describing prospective studies that report amenorrhea rates, patient satisfaction, and surgical reintervention rates following the NovaSure endometrial ablation procedure.
Methodology: Ten prospective studies, six single-arm NovaSure trials and four randomized controlled trials were reviewed for amenorrhea rate, success rate, reintervention rate and patient satisfaction. The follow-up period for these measures was 6-60 months.
The following data reflects real world, peer-reviewed, 12-month outcomes, from prospective single-arm publication studies and randomized control trials published between 2002 to 2015. These studies evaluate pre-menopausal patients who underwent NovaSure endometrial ablation for the treatment of Abnormal Uterine Bleeding.
12-month outcomes for NovaSure endometrial ablation based on ITT population:
1. Hologic, Inc. Data on file; 2004-2016. Based on units shipped from 2004-2016.