 |
| courtesy: mirabilis.com |
Mirabilis Medical, a Seattle based
company received CE Mark authorization for marketing of the Mirabilis System
for treatment of uterine fibroids throughout the European Union. It also announced that it had received a green
signal from US-FDA to begin its clinical studies in US.
The Mirabilis system is a High-Intensity
Focused Ultrasound (HIFU) system consists of an ultrasound system that has two
parts: the imaging part and the therapy part.
The imaging part works like any other
diagnostic ultrasound system and is used to precisely diagnose and locate the
fibroids in the uterus. The therapy part of the system then uses a large bowl
shaped transducer, that focuses the ultrasound beam on the fibroid to ablate
it. It uses the same principle as magnifying glass to focus the sun’s rays.
The proprietary robotically assisted
technology uses a “shell” ablation to ablate outer fibroid tissue which creates
a ‘shell’ of ablated tissue that interprets perfusion to the remaining central
tissue leading to death of the tissue.
The technology allows for the whole
treatment to be complete in 10 minutes as a medical office visit.
“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 US study of the Mirabilis System (DIANA
study) consisting of 180 patients is intended to begin in second half of 2017
and will be conducted at up to 12 clinical sites in the US, Canada, and Europe.
Successful completion will lead to marketing approval of the system in the
United States. The inclusion criteria included women aged 18 to 55, with
fibroid size of up to 7+ cm, who were seeking relief from fibroid symptoms.
Mirabilis has already completed multicenter
pilot study of 73 adult patients in Mexico. (ClinicalTrials.gov Identifier: NCT01946178).
According to a fact sheet by U.S.
Department of Health and Human Services Office on Women’s Health, about 30
percent of all women will get them by age 35, and about 20-80 percent of women
will do so by age 50. It was the most common indication for hysterectomy
between 2000 to 2004, but is dropping rapidly because of other options available
for its treatment.[1]
Currently, about 40% of all
hysterectomies are performed to treat uterine fibroids with approximately $2.5
billion in annual U.S. spending.
It was also featured in an article in
the latest newsletter of the Focused Ultrasound Foundation, the article can be
accessed here.
SOURCE
Mirabilis Medical, Inc.
