Mirabilis Medical Wins CE Mark for Uterine Fibroids
Mirabilis Medical has been granted a CE Mark to market their robotically assisted, non-invasive ultrasound system to treat uterine fibroids.
The device uses a “shell” technique for removal of body tissue. The method ablates only outer fibroid tissue, creating a shell of ablated tissue; the ablated tissue interrupts perfusion to tissue inside the shell, leading to death of additional fibroid tissue.
The clearance was granted based on the completion of an initial clinical trial, which treated 73 women in Mexico with an average active treatment time of less than 10 minutes.
The company has also been cleared by the FDA to conduct a pivotal study in the U.S., which will start in the second half of this year. A total of 180 patients will participate in the trial at 12 sites, including nine in the U.S., two in Canada, and one in Germany. — Cynthia Jessup