|Ablation device--Courtesy of Minerva Surgical|
The FDA gave its stringent PMA approval to Minerva Surgical's Endometrial Ablation System to treat excessive bleeding in premenopausal women that's due to benign causes, and for whom childbearing is complete.
The device uses ablation, or the destruction of tissue, in this case in the endometrial lining of the uterus, to achieve its goal. Excessive bleeding at menstruation is also referred to as menorrhagia.
The system consists of an electrode array that's deployed from the body of the device and into the uterine cavity. The ablation device is connected to a controller which has a touch screen display.
Oddly, Minerva has not yet publicized the achievement, which has gone unreported and actually occurred a month ago, according to the just-released FDA approval letter, dated July 27.
In October, an SEC filing revealed that the company raised $25 million in support of its ablation device. At that time the Silicon Valley company was in the middle of a comparative clinical trial to test the efficacy of the device to "hysteroscopic rollerball endometrial ablation in reducing menstrual blood loss at 12 months post-treatment," according to ClinicalTrials.Gov.
In the approval letter, the FDA says that the Minerva Endometrial Ablation System will be subject to two post-market studies. A single-arm, non-randomized one will provide data on two- and three-year outcomes, including uterine bleeding, compliance with contraception and pregnancies. The one-year outcomes data from the study was provided during the premarket approval process.
Another study will also provide similar outcomes data. The two-armed, randomized control study will continue to compare Minerva's ablation system to rollerball endometrial ablation, and provide one-, two-, and three-year outcomes data. The 30-day safety outcomes were provided premarket.
At press time, Minerva has not made a representative available to FierceMedicalDevices comment.
- read the approval letter from the FDA (PDF)