From the January 2014 issue of HealthCare Business News magazine


“The main advantage and value proposition [of FUS for uterine fibroids] for the patient is that you have a non-invasive treatment that is outpatient and recovery is a day or two,” says Andreae.

Plus with FUS treatment for uterine fibroids, women still have a chance of having kids —something that is not typically possible with a hysterectomy.


“We see a clear demand from women for a uterus sparing procedure,” says Andreae. “Especially as women have children later and the chance of uterine fibroids increases in your thirties.”

Kassell believes FUS for the treatment of fibroids highlights why the timing is just right for the technology to take off in the U.S., where health care reform is rewarding a system centered on cutting costs and rewarding more outpatient procedures.

But commercial success in the U.S. of FUS to treat uterine fibroids depends largely on reimbursement — currently of which there is none.

On the road to reimbursement
Reimbursement has been one of the biggest challenges for FUS adoption in the U.S., according to Susan Klees, communications director at the Focused Ultrasound Foundation.

“If it doesn’t have widespread reimbursement, then adoption is going to be slow because people won’t want to invest in the technology,” she says. Even so, some patients who have been treated with FUS have been able to successfully work with their payors to be reimbursed for it.

Although FUS treatment for uterine fibroids is currently not reimbursed in the U.S., there are many efforts in the works to try and change that.

Philips is still running its phase 3 randomized control trial — SOPHIA — to help gather objective data that will be used to help gain reimbursement for the treatment of uterine fibroids with FUS. In addition, InSightec and Philips, along with the Focused Ultrasound Foundation, have initiated a global registry, called RELIEF, to record both the clinical outcomes and economic data over a three-year period on FUS for the treatment of uterine fibroids. The idea is to treat 1,000 patients over a two-year period and then spend a year following up to get the clinical data, says Philips’ Andreae.

It’s a no-brainer that HIFU’s success hinges greatly on the results of clinical trials going on now, as well as others that are planned for the near future.

In the works
FUS isn’t all that new. Lars Leksell helped develop the technology in the 1950s to treat functional brain disorders, but eventually abandoned the idea because it was hard to pinpoint the affected areas of the brain through the skull without advanced imaging, like MRI, which is key because the clinician needs to be able to image and test the target as well as measure the temperature during treatment. Leksell instead went on to invent the gamma knife in the late 1960s.

January 2014 Magazine

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