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NovaSure endometrial ablation

Abnormal uterine bleeding (AUB) can dramatically affect a woman's comfort, confidence and quality of life. To help women with AUB reclaim their lives, Hologic offers NovaSure endometrial ablation, a safe, simple solution used by more than 2 million women since it was FDA-approved in 2001.

The NovaSure system enables you to provide comfortable customized ablation procedures right in your office or in the operating room. Using radiofrequency impedance-based technology, the NovaSure system delivers the fastest treatment time of any system of its kind, with no hormonal pretreatment required. And, it can be performed any time during a woman's cycle.

About

NovaSure endometrial ablation is a one-time, customized treatment for women who suffer with AUB. This 5-minute procedure can be performed in the office or operating room, and over 90% of women return to normal, light or no periods at all. The NovaSure procedure is a safe and effective way to improve the lives of patients with AUB.

Prevalence, Characteristics and Causes

AUB is more common than most women think. It’s estimated that AUB affects 1 out of every 5 women — that’s about 10 million women!1

AUB is characterized as menstrual bleeding that is unrelated to normal menstruation. A normal period cycle is typically about 28-35 days with bleeding lasting 5-7 days.2 Women with AUB experience much heavier bleeding for longer periods of time than what is considered a normal menstrual cycle. One of the most common symptoms of AUB is heavy menstrual bleeding that lasts for more than 7 days, which may require double protection or affect quality of life.AUB is also characterized by bleeding in between periods, after sex, for more than 35 days or less than 21, and spotting during the menstrual cycle.4

 

 

Our Technology

The unique, radiofrequency impedance-based technology available with the Hologic NovaSure system customizes patient results, delivering:

  • Quick and controlled bipolar radiofrequency (RF) energy —  a proven ablation modality in many surgical specialties.
  • A customized ablation when the scientific endpoint of 50 ohms of impedance or 2 minutes is reached.
  • Individual cavity measurements for each patient, enabling you to tailor the treatment to the specific patient.
  • The only system with a proprietary proactive safety check prior to the procedure to assess cavity integrity; insufflating the cavity using CO2, the system can detect pressure leaks to confirm uterine cavity integrity. 
  • A unique moisture transport system, which ensures tissue contact with the array and removes steam, blood and other byproducts; removal of steam during the procedure is essential to maintaining a controlled ablation.
  • Treatment regardless of a patient's cycle and without any pretreatment required.
Features

Innovative features of NovaSure endometrial ablation system include:

  • Bipolar RF energy.
  • Proactive cavity integrity assessment.
  • Proprietary moisture transport system.
  • Scientific endpoint.

Hologic's next generation NovaSure endometrial ablation system also offers: ​

  • RFC10 controller — enhanced with a touchscreen interface and  intuitive graphics for improved workflow. 
    • The ablation timer and summary screen display cumulative running ablation time and total ablation time at the end of the procedure, as well as length, width and power level. The prior procedure data is also recoverable if the controller is powered off and on.
    • With IFU procedural instructions on the interface, the RFC10 controller walks a physician through corrective actions when an error message is encountered.
    • The volume-controlled and mutable alarms are perfect for in-office procedures during which a patient can be easily startled.
Performance Data

The NovaSure endometrial ablation system is a global market leader that delivers outstanding results:

  • 97% avoidance of hysterectomy at 5 years.5
  • 9 out of 10 patients return to normal levels of bleeding or less.6
  • 93% patient satisfaction reported in a pivotal trial.7
  • Superior results in comparison studies with other treatment options for AUB.8
  • Average 90-second treatment time.
  • No uterine distention.
  • 73% of patients in the pivotal trial received IV or local sedation.6
  • 97% of patients experienced no procedural pain at less than 24 hours. 7
  • 99% of patients experienced no procedural pain from 24 hours to 2 weeks.7
ISI

Important Safety Information:

NovaSure is for premenopausal women with heavy periods due to benign causes who are finished childbearing. Pregnancy following NovaSure can be dangerous. NovaSure is not for those who have or suspect uterine cancer, have an active genital, urinary or pelvic infection or an IUD. NovaSure 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.

For more information please review the instructions for use.

References

1. National Women’s Health Resource Center. Survey of women who experience heavy menstrual bleeding. Data on file; 2005.

2. Menstrual Cycle: What’s Normal, What’s Not. The Mayo Clinic. http://www.mayoclinic.com/health/menstrual-cycle/MY01541.

3. Albers J, Hull S, Wesley R, Southern Illinois University School of Medicine, Springfield, Illinois. “Abnormal Uterine Bleeding.” Am Fam Physician. 2004. Apr 15;69(8):1915-1926. http://www. aafp.org/afp/2004/0415/p1915.html?printable=afp

4. FAQ. The American College of Obstetricians and Gynecologists. http://www.acog.org/~/media/For%20 Patients/faq095.pdf?dmc=1&ts=20130613T1302316232

5. Cooper J, 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.

6. National Women’s Health Resource Center. Survey of women who experience heavy menstrual bleeding. Data on file; 2005.

7. NovaSure Instructions for Use.

8. Gimpelson R, Ten-year literature review of global endometrial ablation with the NovaSure device, Int J of Women’s Health, 2014.