Minerva is a registered trademark of Minerva Surgical Inc.
The Information is for use only in countries with applicable health authority product registrations. The information on this Site is provided for informational purposes only and is not intended or recommended as a substitute for professional medical advice or for diagnosis purposes.
Federal Law (USA) restricts these devices to sale by or on the order of a physician. Refer to Operators Manual for complete Indications for Use, Contraindications, Warnings and Benefit/Risk Determination.
Summary of Safety and Effectiveness Data on file at www.FDA.gov: 1. Minerva®, PMA P140013: Summary of Safety and Effectiveness Data 2. NovaSure®, PMA P010013: Summary of Safety and Effectiveness Data 3. HTA®, PMA P000040: Summary of Safety and Effectiveness Data 4. Her Option®, PMA P000032: Summary of Safety and Effectiveness Data 5. Minerva Surgical®, Endometrial Ablation System Operator’s Manual 6. Her Option®, Cryoablation Therapy System User Manual. 030-02096-001 Rev. W. Cooper Surgical. 2/15 7. "Patient Benefits." Her Option®. Cooper Surgical, n.d. Web. 24 Feb. 2017. <https://www.heroption.com/Professionals/Benefits/PatientBenefits.aspx>. (These products were not studied concurrently in a comparative trial). 8. Philippe Laberge, MD, FRCSC, ACGE, et al. "One-Year Follow-Up Results of a Multicenter, Single-Arm, Objective Performance Criteria–Controlled International Clinical Study of the Safety and Efficacy of the Minerva Endometrial Ablation System." Journal of Minimally Invasive Gynecology Vol 22, No 7 (November/December 2015): 7. 9. ThermaChoice III. Instructions for Use. Ethicon, Inc., 2010. 10. Microsulis Microwave Endometrial Ablation Instructions for Use. Microsulis Americas, Inc. 2002. *Summarized based on data provided in Operator’s Manual and Summary of Safety and Effectiveness Data. 11. Minerva Pivotal Study One-Year Report; 2015. 12. “Heavy Menstrual Bleeding” The American College of Obstetricians and Gynecologists, June 2016.