Minerva Surgical publication: device company used Alkaline Hematin as quantitative endpoint marker for PMA approval

A study was recently published reviewing the safety and efficacy of the Minerva Endometrial Ablation System. The Minerva Endometrial Ablation System is the first device to be evaluated and approved by the FDA using the new Objective Performance Criterion control. A major strength of this study was the use of the Alkaline Hematin (AH) assay to quantitatively measure the amount of blood loss compared to the less accurate Pictorial Blood Loss Assessment Chart (PBLAC) method. Using the Alkaline Hematin assay, the Minerva Endometrial Ablation System was proven to be statistically superior to the hysteroscopic rollerball ablation method.


A valuable outcome of this study shows the use of AH as a validated, quantitative, highly precise and accurate method for assessment of blood loss. This study used AH quantitative data to statistically show the Minerva Endometrial Ablation System is superior to comparator device. This supports AH as a strong asset for other device companies seeking approval from the FDA. The AH assay provides tangible, quantitative data to support more exact, more scientifically sound results proving value of a new product in the marketplace.


Click here to read the full study: A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results


Learn more about KCAS’ Alkaline Hematin department