Mirabilis has announced CE mark authorisation to market the Mirabilis System in the European Union. The system combines high-speed therapeutic ultrasound technology with an advanced robotic system for uterine fibroid treatment.
The company simultaneously announced receiving approval from the US FDA to begin a clinical study of the Mirabilis System in the USA.
Approximately 25% of all women suffer from symptomatic uterine fibroids at some point in their lives, with annual US spending on fibroid treatment exceeding US$2.1 billion according to the National Institutes of Health. Over 40% of all hysterectomies are performed to treat fibroids.
Current treatments for uterine fibroids typically involve an invasive surgical procedure that can include endometrial ablation, myomectomy, and hysterectomy. In addition to the cost, surgical risk, and recovery time of such procedures, they often result in infertility.
The system treats uterine fibroids non-invasively by focusing ultrasound energy into the fibroids from outside the body; there is no incision involved. The procedure is performed by a physician placing the system on a woman’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. Proprietary Mirabilis technology allows typical treatments to be completed in less than ten minutes in a medical office, as opposed to several hours in a hospital for some alternatives.
“The Mirabilis System has been in development for nearly ten years, and it is very exciting to now be able to bring this technology to market,” said Jens U Quistgaard, president and CEO of Mirabilis. “This technology holds the promise of helping a large number of women worldwide, and we’re very pleased to be able to begin making it available.”
The Mirabilis System is currently restricted to investigational use in the USA, however, the company expects to begin a clinical study later this year intended to lead to US marketing approval. The Mirabilis DIANA study is planned to be conducted at 12 clinical sites in the US, Canada, and Europe.