Over 15 years of real-world experience – NovaSure Endometrial Ablation
More than 3 Million patients treated1
Abnormal uterine bleeding (AUB) can dramatically affect a woman’s comfort, confidence, and quality of life. The NovaSure endometrial ablation procedure is a simple way to reduce or stop menstrual bleeding for women with AUB.
- It’s quick — one time, five-minute procedure.
- It’s safe and effective — proven with 15 years of demonstrated clinical performance.
- It’s simple — this minimally invasive procedure can be done in a doctor’s office.
For 77.7% of women, menstrual bleeding is successfully reduced or stopped within one year.
NovaSure Procedure Efficacy
What you need to know about the NovaSure procedure
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 3 million procedures have been performed.1
THE NOVASURE DEVICES
Comfort, control, confidence
The NovaSure ADVANCED and CLASSIC devices, which include a 3-dimensional bipolar electrode, deliver continuous suction to ensure proper contact with the endometrium and to remove vaporized tissue. An integrated proactive safety test is performed prior to the delivery of radiofrequency (RF) energy; insufflating the cavity using CO2, the system can detect pressure leaks to confirm uterine cavity integrity. The assessment is sensitive enough to detect a perforation as small as an 18-gauge needle.
Both the NovaSure CLASSIC device and the NovaSure ADVANCED device are designed to focus on patient comfort and ease of use, providing the tools to allow you control at every step:
Now that I’ve had the NovaSure
procedure, I have a new life!
Janelle Shaw, NovaSure Patient
- Hologic, Inc. Data on file; 2004-2018. Based on units shipped from 2004-2018.
- NovaSure Instructions for Use. Marlborough, MA: Hologic, Inc.
*Based on PMA approval in 2001
†Based on internal bench testing that measured perceived ease of insertion through a simulated cervix of both the 6-mm and 8-mm devices. N=16 surgeon users.
IMPORTANT SAFETY INFORMATION
NovaSure® endometrial ablation is for premenopausal women with heavy periods due to benign causes who are finished childbearing. Pregnancy following the NovaSure procedure can be dangerous. The NovaSure procedure is not for those who have or suspect uterine cancer; have an active genital, urinary or pelvic infection; or an IUD. NovaSure endometrial ablation is not a sterilization procedure. Rare but serious risks include, but are not limited to, thermal injury, perforation and infection. Temporary side effects may include cramping, nausea, vomiting, discharge and spotting. Inform patients to contact you if they experience a possible side effect related to use of this product. For detailed benefit and risk information, please consult the IFU.