The development of new devices is a never-ending process. There is one more device that has added to the list by earning a CE mark for marketing the Mirabilis System by Mirabilis Medical in the European Union. And also, the company has received a grant from the Food and Drug Administration to initiate a clinical trial of the Mirabilis System in the US. The system merges an advanced robotic system with rapid therapeutic ultrasound technique for the treatment of uterine fibroid.
Fibroids are a type of benign uterus tumors that can considerably impact the woman’s quality of life, resulting in prolonged & heavy menstrual bleeding, urinary urgency & frequency, pelvic cramps, and infertility or pregnancy loss. The existing uterine fibroids treatments usually involve a surgical procedure that is invasive and can also damage the lining of the uterine to decrease bleeding, hysterectomy, and cut out the fibroids. Apart from the price, recovery time and surgical risk of such processes, they mostly result in infertility.
The Mirabilis System is designed for uterine fibroids treatment in a non-invasive way by fixing the ultrasound energy from the exterior of the body into the fibroids, i.e., there is need of cutting. The process is carried by a physician mounting the Mirabilis System onto the abdomen of a woman, detecting the fibroid with the use of inbuilt ultrasound imaging, and then choosing the region of the fibroid to be treated. Under the control of the physician, the system then treats the fibroid automatically with the use of a robotic motion system. The Mirabilis technology permits the completion of usual treatments in less than 10 minutes in comparison to a number of hours in a hospital.
At present, the Mirabilis System is limited to investigational usage in the United States; though, the company anticipates to initiate a clinical trial later on this year wishing to lead to the US marketing consent. The Mirabilis DIANA trial is considered to be performed at 12 clinical sites in the Canada, Europe, and the United States.