U.S. FDA Approves Minerva Endometrial Ablation System

Share Article

92% of Clinical Study Patients had Their Heavy Menstrual Bleeding Reduced to a Normal Level or Less.

Minerva Plasma Formation Array

Minerva Plasma Formation Array

There’s a new treatment option for excessive menstrual bleeding – The Minerva Endometrial Ablation System. Minerva is the first commercially available new FDA approved system in the last 14 years, and the only endometrial ablation product to combine the high treatment Success rate of 92%, the high Amenorrhea (zero bleeding) rate of 66%, the high Patient Satisfaction rate of 98%, and the fastest procedure time (3 to 4 minutes) in clinical trials conducted for FDA approval.

Minerva is indicated for ablation of the endometrial lining of the uterus in pre-menopausal women suffering from excessive menstrual bleeding due to benign causes for whom childbearing is complete.

In a large-scale, international, multi-center clinical trial, 92% of patients treated with Minerva, reported a reduction in menstrual bleeding to normal level or less and 66% reported zero bleeding, at 12 months post-procedure. The results of this study were reviewed and the manuscript entitled “One-Year Follow-Up Results of a Multi-Center, Single-Arm, Objective Performance Criteria–Controlled International Clinical Study of the Safety and Efficacy of the Minerva Endometrial Ablation System” was accepted for publication in the Journal of Minimally Invasive Gynecology, JMIG, a peer-reviewed medical journal published by the American Association of Gynecologic Laparoscopists. http://archive.aagl.org/jmig-22-6-JMIG-D-15-00207

“The developers of the Minerva technology have more than 30 years of experience bringing innovative minimally invasive solutions to women’s healthcare. The Minerva Treatment represents a paradigm shift in overall clinical outcomes and is an excellent solution for women suffering from excessive menstrual bleeding,” said Eugene Skalnyi, MD, Vice President of Medical Affairs at Minerva Surgical. “After 6 years of extensive research and development, and two multi-center, international clinical studies, doctors and their patients can now consider Minerva as a treatment of choice for excessive menstrual bleeding."

About Excessive Menstrual Bleeding (Menorrhagia)
Excessive menstrual bleeding is a very common problem that affects about 1 in 5 women. Many women also say that excessive menstrual bleeding makes it difficult to work, exercise, and be socially and sexually active. The signs of heavy bleeding are most likely to start between the ages of 30 and 40.

About the Minerva Endometrial Ablation System
The Minerva System works by applying heat via three complementary ablation mechanisms to adequately ablate (destroy) the endometrium, the inner lining of the uterus. Endometrial tissue is the likely source of heavy bleeding in many women who have not reached menopause. The total procedure time from insertion to removal of the Minerva device is 3 to 4 minutes. As with any surgery, there are risks related to the treatment and/or anesthesia used during the treatment. Your doctor will talk to you about the risks of the Minerva treatment and give you details about your individual situation.

About Minerva Surgical
Minerva Surgical, Inc., founded in 2008 by Csaba Truckai and a group of experienced medical technology engineers, is a private medical device company based in Redwood City, CA. The company's efforts are focused on delivering next generation products for women’s healthcare. For more information on Minerva Surgical visit us at: http://www.minervasurgical.com.

Media Contact:
Brian Ahmann 855-646-7874 or Brian(at)minervasurgical(dot)com

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Brian ahmann
Minerva Surgical
+1 6502843500 Ext: 1751
Email >

Brian Ahmann
Visit website