• Clinical Study Data

    The Minerva System has been clinically tested in rigorous studies for FDA approval. One year after treatment, patients reported significantly reduced menstrual bleeding with a Success Rate of 93% (bleeding reduced to normal level), and Amenorrhea Rate of 72% (bleeding was completely eliminated).

†The objective performance criterion (OPC) is 66% based on the lower bound of the 95% confidence interval (LB 95% Cl) of the average success rate of the five previously approved global endometrial ablation (GEA) devices measured by PBLAC method. Success in the Minerva RCT was achieved when bleeding was reduced to AH Value of ≤80ml at 12 months after the endometrial ablation procedure. Amenorrhea was defined as a score of 0.1 Secondary study endpoints included the amenorrhea rate, length of procedure (hand piece insertion to removal), and responses from a patient satisfaction questionnaire.1 MEA and ThermaChoice were included in the OPC but are no longer for sale in the United States.

*Not based on a head-to-head study. Data from intent-to-treat populations at 1-year follow-up in the Instructions for Use for Minerva®, Her Option®, HTA® System, and NovaSure®.

  1. Minerva Endometrial Ablation System [Operator’s Manual]. Redwood City, CA: Minerva Surgical, Inc; 2017.
  2. NovaSure Impedance Controlled Endometrial Ablation System [Instructions For Use and Controller Operator’s Manual]. Marlborough, MA: Hologic, Inc; 2014.
  3. Her Option Office Cryoblation Therapy [package insert]. Minnetonka, MN: American Medical Systems, Inc; 2007.
  4. Genysys HTA ProCerva Procedure Set [instructions for use]. Marlborough, MA: Boston Scientific Corporation; 2014.

Comparison of Endometrial Ablation Systems

REFERENCES: 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 2017;
  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. (These products were not studied concurrently in a comparative trial);
  8. Summarized based on data provided in Operator’s Manual and Summary of Safety and Effectiveness Data.

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