Mirabilis Medical, a Seattle-area developer of advanced medical technology for non-invasive surgery, announced today CE Mark authorization for marketing of the Mirabilis System for treatment of uterine fibroids throughout the European Union.
The company simultaneously announced that it had received approval from the US Food and Drug Administration to begin a clinical study of the Mirabilis System in the United States. The Mirabilis 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.
Fibroids are benign tumors of the uterus that can substantially impact the quality of a woman's life, causing heavy and prolonged menstrual bleeding, pelvic cramps, urinary frequency and urgency, and pregnancy loss or infertility.
Approximately 25% of all women suffer from symptomatic uterine fibroids at some point in their lives, with annual U.S. spending on fibroid treatment exceeding $2.1 billion according to the National Institutes of Health. Over 40% of all hysterectomies (surgical removal of the uterus) are performed to treat fibroids.
Current treatments for uterine fibroids typically involve an invasive surgical procedure that can include destroying the uterine lining to reduce bleeding (endometrial ablation), cutting out the fibroids (myomectomy), and hysterectomy. In addition to the cost, surgical risk, and recovery time of such procedures, they often result in infertility.
The Mirabilis System treats uterine fibroids non-invasively by focusing ultrasound energy into the fibroids from outside the body – no cutting is involved. The procedure is performed by a physician placing the Mirabilis 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's 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 United States, 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.