NovaSure® Endometrial Ablation

Over two decades1 of real-world experience in endometrial ablation.

Information for Healthcare Professionals

Gloved hand holding medical device in a lab setting.

    Overview

    Documents

    Comfort, Control, Confidence

    Heavy Menstrual Bleeding (HMB) can dramatically affect a woman’s comfort, confidence and quality of life. The NovaSure endometrial ablation procedure is a one-time, five-minute,2 minimally invasive procedure, to reduce or stop HMB. The procedure is typically performed in an operating theatre, but under some circumstances may be performed in an outpatient setting.

    Smart Depth Technology

    The NovaSure procedure utilises unique, patented 'smart-depth-technology' to deliver customised ablation.

    Smart

    The technology continuously monitors and measures tissue impedance and calculates the optimal power level required to treat  the cavity, based on uterine size.

    Unique

    Our unique SureClear™ fluid removal system provides constant tissue contact with the array through integrated suction. It simultaneously removes steam, blood, and other by-products. 

    Safety

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

    Innovative

    Over 3 million procedures performed worldwide3 has driven continuous design improvements over the years based on user feedback.

    Two women hiking up a hill at sunset

    Improving Patient Care is Within Your Control

    For many women, the diagnosis and treatment of uterine disorders is a long, painful and  frustrating journey. Our team pioneers gynaecological diagnostic and surgical solutions that give professionals greater confidence in patient diagnosis and more choice over treatment options.             

    NovaSure Endometrial Ablation is part of the Hologic Uterine Health Portfolio.

    Over 20 years of clinical data1

    3+ Million

    patients treated worldwide3

    96%

    of women had reduction in bleeding at 5 years4

    90%

    avoided hysterectomy4

    92.8%

    patient satisfaction5

    Explore the Device

    Utilises patented technology to deliver customised ablation to each patient. The device is inserted through the cervix into the uterus and emits precisely measured radio-frequency energy to remove the endometrium, the uterine lining that sheds during a period.

    The NovaSure Endometrial Ablation System

    The system consists of a controller and handheld disposable device. The design has been improved five times since launch, working in close collaboration with customers. However, the core technology has remained the same due to its track-record and proven efficacy.

    Empowering Women with Knowledge

    Providing women with clear, easy to understand information about heavy menstrual bleeding and treatment options is essential for informed, shared decision making. We have created a patient education website with information on heavy periods, treatments available for you to have conversations with your patients. This will help to empower these women to take the first step to live comfortably.

    Insights

    Woman holding her stomach on a sofa.

    Update to Clinical Care Standards Aims to Reduce Invasive Procedures for Heavy Periods

    Woman on a sofa with her arms wrapped around herself

    Australian Research Reveals that 72% of Women Have Experienced Heavy Menstrual Bleeding

    Surgeon looking into camera in an operating theatre

    Hysterectomy and its Future Role in Uterine Health

      1. Based on PMA approval in 2001
      2. NovaSure Advanced IFU AW-09898-001 Rev. 10: 10-17
      3. Hologic, Inc. Data on file; 2004-2018. Based on units shipped from 2004-2018.
      4. Smith PP, Malick S, Clark JT. Bipolar Radiofrequency Compared With Thermal Balloon Ablation in the Office A Randomized Controlled Trial. Obstet Gynecol. 2014 Aug;124 (2 Pt 1):219-25
      5. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety and efficacy of the Novasure System in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002; 9:418-428

      Safety Data Sheets

      Package Inserts

      2797

      Hologic BV, Da Vincilaan 5, 1930 Zaventem, Belgium.

      Notified Body number wherever applicable

      EC Representative Information wherever applicable