Mirabilis Medical's Ultrasound Treatment for Uterine Fibroids Approved in Europe

March 23, 2017—Mirabilis Medical announced that its system for treating uterine fibroids has received European CE Mark approval. The company also announced receipt of US Food and Drug Administration approval to begin a clinical study of the Mirabilis system in the United States.

According to the company, the Mirabilis system noninvasively treats uterine fibroids by focusing ultrasound energy into the fibroids from outside the body. The system combines high-speed therapeutic ultrasound technology with an advanced robotic system to allow treatments to be finished within minutes in a medical office setting.

The procedure is performed by a physician placing the Mirabilis System on the patient's abdomen, locating the fibroid using built-in ultrasound imaging, and selecting the area of the fibroid to be treated. Under physician control, the device then automatically treats the fibroid using a robotic motion system. A typical treatment can be completed in less than 10 minutes in a medical office, stated Mirabilis Medical.

In the United States, the Mirabilis system is currently restricted to investigational use. The company expects to begin the DIANA clinical study in 2017 at 12 clinical sites in the United States, Canada, and Europe and is intended to support marketing approval in the United States.