Nearly two decades* of real-world experience – NovaSure Endometrial Ablation

3 Million patients treated and counting!1

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 over 15 years of demonstrated clinical performance.
  • It’s simple — this minimally invasive procedure can be done in a doctor’s office.

In the pivotal study of the NovaSure system, 92.8% of patients were satisfied with the NovaSure procedure.2

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%.2 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:


 

SMART-DEPTHTM TECHNOLOGY
Smart

The technology continuously monitors and measures tissue impedance and calculates the optimal power level required for the treatment of the cavity – based on uterine size.

smart

Unique

Our unique Moisture Transport® fluid removal system provides constant tissue contact with the array through integrated suction while simultaneously removing steam, blood, and other by-products.

unique

Safe

The Cavity Integrity Assessment (CIA) is a built-in safety test that confirms uterine cavity integrity, giving you the confidence to perform a safe and effective ablation for every patient.

safe

Now that I’ve had the NovaSure
procedure
, I have a new life!

Janelle Shaw, NovaSure Patient
References
  1. Hologic, Inc. Data on file; 2004-2018. Based on units shipped from 2004-2018.
  2. 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.