NovaSure®️ endometrial ablation: still innovating after all these years

In 2001, the NovaSure global endometrial ablation (GEA) procedure was approved by the U.S. Food and Drug Administration (FDA). This one-time, five-minute procedure to reduce or stop menstrual bleeding for women with abnormal uterine bleeding (AUB) has transformed the GEA market since its launch, and we are proud to be the market leader today.1

AUB is a common issue that affects as many as 1 in 3 women,2 and physicians like you have relied on the NovaSure procedure to help over 3 million women3 discover a simple way to reduce or stop AUB for improved comfort, confidence, and quality of life.

How does one procedure remain the most trusted, most widely used choice for over two decades?

It started with technology that revolutionized GEA
To be clear, the NovaSure procedure wasn’t the first GEA procedure on the market. However, it was the first GEA that changed the market, thanks to unique technology that offers a clear clinical differentiator to other products.

NovaSure GEA features SureClear™ technology, which provides constant contact with the array while suctioning vapor, blood, and desiccated endometrium.4

Furthermore, NovaSure GEA is the only device featuring SmartDepth™ technology, which continuously monitors and measures tissue impedance to ensure a customized and reproducible depth of ablation for every patient. This means you can provide a customized, reproducible ablation based on a patient’s cavity size. The NovaSure procedure is the only GEA designed to terminate upon reaching a clinical endpoint.

Today, NovaSure GEA remains the gold standard, with proven efficacy and safety backed by more than 80 peer-reviewed publications5 and a patient satisfaction rate of 94% at 24 months.4

It continues with product evolution influenced by you
The NovaSure portfolio has expanded over the years, and in many ways, the device enhancements have been a direct response to what you—physicians—have told us you need. In 2016, we introduced the NovaSure ADVANCED device, which requires 14% less dilation6 than a competitive GEA device and features rounded tips in an innovative 6-mm sheath for ease of insertion.7

And then, in November 2021, the NovaSure V5 device hit the market. When developing this device, we spoke to you and the women you treat. You asked for enhanced accuracy, of course. But you also asked for greater customization—ideally, a device that would offer the ability to adapt to varying patient anatomy. Here’s what we delivered:

  • AccuSheath™ markings designed to improve the accuracy and confidence in device placement and seating8,9
  • A newly designed cervical seal featuring EndoForm™ technology designed to increase the sealing surface and accommodate a range of cervical canals10-12
  • Still featuring SureClear™ fluid removal system, which provides integrated suction through the array by constant tissue contact even in irregular anatomy while simultaneously removing ablation byproducts such as vapor and fluid from the uterus9

The NovaSure V5 device, born from a need to accommodate the individual patient on the table, is now the most sophisticated GEA device in our portfolio. Even now, more than 20 years after the NovaSure device was introduced, we are continuously working to enhance this groundbreaking procedure.

Dr. Kelli Miller, MD, the first physician to perform the NovaSure procedure with the V5 device, shares, “I have used NovaSure for 20 years and consider it the gold standard in treatment for patients with menstrual disorders. I didn’t think there was room for improvement; however, the V5 updated cervical seal feature has exceeded my expectations. The markings added to the sheath correspond with the uterine sound measurement, further reassuring me of accurate placement. Ultimately, every woman has unique anatomy, and the cervical seal contours to a range of cervical canals, providing an advanced treatment option. Best of all, the V5 does not require a steep learning curve, allowing the improvements to be even more appreciated by the physician.”

The innovation and enhancements built into the NovaSure V5 device reflect our ongoing commitment to advancing minimally invasive procedures and empowering you to raise the standard of care for your patients. Together, we are improving the quality of life for so many women who suffer from AUB.

To learn more about the NovaSure system, contact your sales representative or click here.

References:

  1. U.S. Market Report Suite for Gynecological Devices. iData Research Inc., 2020.
  2. The American College of Obstetricians and Gynecologists. FAQs: Heavy Menstrual Bleeding. https://www.acog.org/womens-health/faqs/heavy-menstrual-bleeding. Last updated May 2021. Last reviewed October 2020. Accessed August 9, 2022.
  3. Hologic, Inc. Data on file; 2004-2018. Based on units shipped from 2004-2018.
  4. NovaSure ADVANCED Instructions for Use.
  5. https://pubmed.ncbi.nlm.nih.gov/ search.
  6. NovaSure ADVANCED Instructions for Use, 6mm dilation as compared to Minerva Instructions for Use 7mm dilation.
  7. 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.
  8. NovaSure V5 Designs Verification Results, VER-10513.
  9. NovaSure V5 Instructions for Use, MAN-07653-001.
  10. NovaSure V5 cervical seal drawing, FAB-18821.
  11. Baggish MS, Karram MM. Chapter 44. In: Atlas of Pelvic Anatomy and Gynecologic Surgery. Philadelphia, PA: Elsevier; 2016:493.
  12. Luo J, Betschart C, Ashton-Miller JA, DeLancey JOL. Quantitative analyses of variability in normal vaginal shape and dimension on MR images. Int Urogynecol J. 2016;27(7):1087-1095.

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.

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