Uterine Fibroids, also referred to as leiomyomas or myomas, are benign muscle tumors in various locations in the uterus that cause a range of symptoms. Insightec’s MR-guided Focused ultrasound (MRgFUS) technology provides uterine-sparing, outpatient treatment option to help relieve symptomatic symptoms from uterine fibroids.
During treatment, ultrasound beams are focused to a focal point — heating and ablating targeted tissue. The treatment is guided by MRI, providing high resolution images of the target and adjacent structures, as well as continuous temperature monitoring. If necessary, parameters can be adjusted to ensure optimal response.
This treatment is incisionless, there is no scarring with minimal side effects, often allowing patients to return to normal activity within days.¹
Important Safety Information
Potential short term complications – those which normally resolve within 10 – 14 days of the treatment
Low blood pressure or fainting during or after procedure; abdominal pain/cramping; nausea; fever; allergic reaction to contrast media or medications; minor skin injury (burns); back or leg pain that persists for a few days; urinary tract infection.
Potential long term complications – those lasting longer than 14 days after treatment
Abdominal skin burn with ulceration; back or leg pain or weakness from nerve damage that may persist for a long period of time, or may be permanent.
Although the following were not reported in clinical trials, there are the potential risks of gynecological infection, damage to organs adjacent to the uterus, blood clots, and death from this treatment. There is also a risk that if your fibroids contain cancer, the diagnosis of cancer could be delayed. This risk applies not only to Exablate, but to any fibroid treatment that does not remove tissue.
For additional safety information, please refer to Pre-Market Approval (PMA) P040003
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