News

News

Mirabilis representatives will be attending the 2017 MEDICA trade show in Dusseldorf, Germany, from November 13-16 2017. Mirabilis will be co-exhibiting in the Washington State / USA stand number 16D10-1 in Hall 16.
Mirabilis is pleased to be featured in an article in the latest newsletter of the Focused Ultrasound Foundation, which discusses Mirabilis' recent European market clearance (CE Marking) and US FDA approval of its pivotal clinical study. The article can be found here

Mirabilis Medical, developer of advanced therapeutic ultrasound technology for non-invasive surgery, announced today CE mark authorization for marketing of its system for the treatment of uterine fibroids throughout the European Union. The Mirabilis system combines high-speed ultrasound technology with an advanced robotic system to allow treatment 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. 25% of all women suffer from symptomatic uterine fibroids at some point in their lives, with annual U.S. spending on fibroids is approximately $2.5 billion. 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 total removal of the uterus (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 device 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 system 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 has the promise of helping a large number of women worldwide, and the company is very pleased to be able to begin making it available."

The Mirabilis system is limited by federal law to investigational use in the United States.

Mirabilis Medical, developer of advanced therapeutic ultrasound technology for non-invasive surgery, announced today that the US Food and Drug Administration has granted unconditional approval to begin a clinical study of the Mirabilis system for the non-invasive treatment of uterine fibroids. The DIANA study is intended to lead to marketing approval of the system in the United States, and is planned to be conducted at up to 12 clinical sites in the US, Canada, and Europe.
Mirabilis has completed a multi-center pilot study, investigating the use of the Mirabilis System for the treatment of uterine fibroids. The Mirabilis System is an ultrasound guided High Intensity Focused Ultrasound (HIFU) device. The study (NCT01946178) enrolled and treated 73 adult patients at clinical centers in Mexico City and Monterrey, Mexico. Interim data has been presented at symposia of the International Society of Therapeutic Ultrasound and at the European Society of Gynaecological Endoscopy annual congresses.
We are pleased to announce that Mirabilis has received ISO-13485 certification for its quality system, covering the "design and development, manufacture, distribution, installation and service of ultrasound devices for the non-invasive ablation of uterine fibroid tissue in the field of Gynecology."
ISO-13485 is an internationally recognized standard for quality systems covering medical devices, and is an important milestone in bringing the Mirabilis system to market in Europe and elsewhere. Audit and certification was performed by Dekra Certification, B.V.

Caution: The Mirabilis System is limited by federal law to investigatinoal use in the United States.