In an exciting development, Health Canada has finally approved focused ultrasound therapy for the treatment of uterine fibroids!
Often referred to as a “scarless” procedure, MRgFUS uses focused, or targeted, ultrasound waves to heat and destroy fibroids using high-frequency, high-energy sound waves without affecting any nearby tissue or organs. MRgFUS treatment for fibroids takes about three hours and is an attractive treatment option for women with abnormal uterine bleeding because it stops your bleeding while sparing your uterus.
I describe MRgFUS in more detail in Chapter 13 of my book, The UnHysterectomy.
During the procedure, patients lie inside the MRI scanner, which produces three-dimensional images of the problematic tissue. This allows physicians (radiologists) to direct precise, high-intensity, focused ultrasound waves into the body at specific targets – the problematic tissue – at temperatures of between 65° and 85°C (149° to 185°F), destroying the tissue. Owing to the thermal imaging provided by the MRI scanner, physicians get real-time feedback on how well the procedure is progressing, which gives them tremendous control over the outcome of the procedure. Each pulse lasts about 15 seconds; pulses are repeated about 50 times throughout the procedure. This particular type of treatment is just an ultrasound beam that’s focused so there’s absolutely no incision, no scarring and very little postoperative care.
Although some women I have interviewed have mixed reviews about the treatment, I believe that anything that puts another tool in the tool box for treating fibroids means women have that many more choices as opposed to undergoing hysterectomy, which is often the first and only treatment they are prescribed.
Here is the news release that came out a few days ago announcing that MRgFUS is now approved in Canada for fibroids….you can be sure I will be following up on this exciting development to see where and how soon it will be available in Canada.
Third generation ExAblate system, using non-invasive MR guided Focused Ultrasound (MRgFUS) now available for Canadian patients
TIRAT CARMEL, Israel, Aug. 22, 2013 /CNW/ – InSightec Ltd, the leader in MR guided Focused Ultrasound therapy, announced that its ExAblate system received approval of Health Canada for MRgFUS treatment of uterine fibroids and for pain palliation of bone metastases.
ExAblate combines high intensity focused ultrasound waves and continuous MRI guidance and monitoring. The focused ultrasound energy is used to heat and destroy the targeted tissue while the MR images are used to guide the energy beam and monitor treatment outcome. ExAblate’s main benefits are that in a single session with this non-ionizing radiation, the treatment allows patients a rapid recovery while minimizing morbidity and trauma with a high safety profile, thus improving patients’ quality of life.
Health Canada’s approval was based on data published from clinical trials conducted in Canada, the USA and Europe. ExAblate received the first approval by the United States FDA in 2004 and is the only MR guided Focused Ultrasound system to have both FDA and Health Canada’s approval. Ten thousand patients globally have already been treated with ExAblate.
Dr. Kobi Vortman, CEO and founder of InSightec, said, “Health Canada’s approval is another vote of confidence in ExAblate’s high safety profile and excellent outcomes. It once again highlights InSightec’s firm commitment to expand clinical indications in gynecology as well as in oncology and neurosurgery.”
InSightec Ltd. is privately held by Elbit Imaging, General Electric, and MediTech Advisors. Founded in 1999 InSightec developed ExAblate to transform MRI-guided Focused Ultrasound (MRgFUS) into a clinically viable technology. ExAblate has won several awards for innovation and its potential to help mankind including The Wall Street Journal Technology Innovation Awards and the European Union’s IST grand prize. TIME magazine recently named Focused Ultrasound as “one of 50 best inventions.” For more information please visit: http://US.InSightec.com.
SOURCE: InSightec Ltd
Congratulations to InSightec for gaining Health Canada approval. Now we just need to find out where Canadian women can access the tretament!