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NovaSure® Endometrial Ablation

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

Information Exclusively Intended for Healthcare Professionals

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    Overview

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    Overview

    Comfort, Control, Confidence

    Abnormal uterine bleeding (AUB) 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 with the intention to help reduce or stop AUB. The procedure can be conducted in an operating room (OR) and 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 Moisture Transport™ 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 effective ablation for every patient.

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    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.

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    Over 20 years of clinical data3

    3+ Million

    patients treated worldwide4

    96%

    of women had reduction in bleeding at 5 years5

    90%

    avoided hysterectomy5

    92.8%

    patient satisfaction6

    Overview of the Procedure

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

    Medical illustration of the NovaSure instrument within the uterus.
    Image of patient room with physician in virtual hospital.

    Visit Our Virtual Hospital

    See how our Uterine Health products work, in both an outpatient  and operating room (OR) setting.

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    The NovaSure Endometrial 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 strong safety record and proven efficacy.

    The-Next-Generation--Introducing-NovaSure®-V5 image on white background

    The Next Generation: Introducing NovaSure® V5

    Based on 20+ years of clinical studies and 3 million procedures performed worldwide, NovaSure V5 features our new patient-centric innovations to deliver an upgraded experience.

     

    • SureClear™ fluid removal system provides integrated suction through the array by constant tissue contact. It simultaneously removes vapour, blood and desiccated endometrium.
    • Endoform™ technology designed to accommodate a range of cervical canals and anatomical variability.
    • AccuSheath™ markings designed to increase accuracy and confidence in device seating and placement.
    • Nominal 6-mm sheath diameter requires approximately 6 mm of cervical dilation. 
    NovaSure-Advanced image on white background

    NovaSure Advanced

    Introduced in 2016, NovaSure Advanced device offers a slimmer 6 mm diameter sheath. It is designed to improve patient comfort and physician ease-of-use, while maintaining the clinical efficacy.

     

    • Nominal 6-mm sheath diameter requires approximately 6 mm of cervical dilation. 
    • Rounded Smooth Access™ tips are design to lessen the force needed for insertion.
    • The cervical seal creates a sealing surface within the cervical canal during proactive cavity integrity assessment and evacuation of procedure by-products.
    • Blue front handle aids insertion technique with a visual reminder to hold only the front handle.
    _NovaSure-RFC10-Controller image on white background

    NovaSure RFC10 Controller

    The NovaSure procedure use a hand held device in combination with a user-friendly, portable controller. It features touchscreen intuitive graphics, designed to streamline the procedure and improve workflow.

    By working closely with customers, our engineers have incorporated several physician-inspired and patient-focused enhancements to the NovaSure RFC10 controller. Here’s how these intuitive graphics help to improve workflow.


    Touchscreen Interface
    The responsiveness of our advanced touchscreen interface is set to react to user input.


    Ablation Timer and Summary Screen
    This displays cumulative running ablation time and total ablation time at the end of the procedure. Length, width and power level are also displayed. The prior procedure data is also recoverable if the controller is powered off and on.


    Procedural Instructions on Interface
    If there is an error message, use the IFU procedural instructions displayed on the interface to perform corrective actions.


    Volume Controlled and Mutable Alarms
    Turn the alarms down (or mute them) so that patients aren’t startled during the procedure. A great feature when performing outpatients procedures.

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    20 Years of NovaSure Innovation

    NovaSure Fundal Block for an outpatient setting

    Empowering Women with Knowledge

    Especially when it’s about things people tend to skirt around, like heavy periods or uterine issues. It’s time to stop waiting and wondering in silence. It’s time to take the next step toward overcoming heavy periods. We have the information that can help.

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    Evidence. Insight. Collaboration.

    Our education portal improves patient care through excellence in education, communication of clinical and scientific evidence, and partnerships with the healthcare community.

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    Insights

    Visit the Hologic Innovation Exchange
    Woman in conversation with a doctor at a medical facility

    Consensus on Abandoning Blind Gynaecological Procedures

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    Hysterectomy and its Future Role in Uterine Health

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    Global Insight: A Vision for Women-centric Care

      References
      1. Based on PMA approval in 2001
      2. NovaSure Advanced IFU AW-09898-001 Rev. 10: 10-17
      3. Based on PMA approval in 2001
      4. Hologic, Inc. Data on file; 2004-2018. Based on units shipped from 2004-2018.
      5. 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
      6. 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

         

      Singapore-registered IFU data is available upon request.
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