由 Brendon Nafziger
, DOTmed News Associate Editor | July 12, 2013
From the July 2013 issue of HealthCare Business News magazine
MR-HIFU treatments of uterine fibroids take about three hours, and work by heating the fibroid to about 65 degrees centigrade, according to Thomas Andreae, with Philips’ MRC Therapy Business Development unit in Helsinki, Finland. “That’s enough to ablate the tissue, but it’s not overheating or putting the patient at too much risk,” he says.
This use is by far the most common application for the technology in the U.S. In fact, so far, InSightec’s ExAblate has only two clinical uses approved by the U.S. Food and Drug Administration (Philips has none): treating uterine fibroids (approved in 2004) and zapping painful bone metastases which don’t respond to medication (approved last October). But the bread-and-butter of the systems is still uterine fibroids, and likely will be for the next few years. InSightec, which in addition to GE is owned by Elbit Imaging and Meditech Advisors, says its ExAblate treats about 1,200 women a year globally.
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“It’s still a small fraction of the potential market,” Eyal Zadicario, vice president of R&D at InSightec, tells DOTmed News.
To strengthen the case for the technology and potentially capture more of that market, InSightec, along with Philips, announced in May the launching of a new treatment registry, RELIEF, to record both clinical and economic data on MR-HIFU fibroid treatments. The goal is to collect data on 1,000 patients, Zadicario says.
For its part, Philips is working to get its MR-HIFU system, the Sonalleve, on the U.S. market soon. The company is still running a phase 3 trial for the FDA, which is recruiting patients at nine sites worldwide, eight of which are in North America. The product has been available in Europe since early 2010, and it’s also for sale in Canada, Korea and a few others countries. About 50 units have been installed globally.
According to Philips, uterine fibroids were a good early candidate for technological, clinical and financial reasons. “(Fibroids are) sitting there in the pelvis and they don’t move and they’re fairly big, and you have a good acoustic window,” says Andreae.
Physician testing fully-awake
patient’s reaction during
But while a good early candidate, for MR-HIFU, uterine fibroids are just the beginning. Currently, InSightec has its transducers pointed next to a neurological disorder: essential tremor.