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Special report: Is focused ultrasound medicine's best kept secret?

by Loren Bonner, DOTmed News Online Editor | January 10, 2014
From the January 2014 issue of HealthCare Business News magazine


Prostate space
One application where FUS is used frequently — and often using ultrasound guidance — is outside of the U.S. for the treatment of prostate cancer.

According to John Rewcastle, medical director for the French company EDAP, over 40 thousand high intensity focused ultrasound procedures for prostate cancer have been performed in Europe. (Some patients get more than one treatment so quoting procedures is more accurate).
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“Fifteen years ago treatment would have been aggressive with a cure at all costs mentality. Now it’s more of a balance of treatment effectiveness with the side effects of the treatment and that’s where we fit in,” says Rewcastle.

In more recent years, evidence has surfaced discouraging aggressive therapy to treat prostate cancer due to the risk of side effects outweighing any benefit of treatment.

In February 2013, EDAP submitted a premarket approval application to the FDA to gain clearance of its Ablatherm-HIFU for treatment of low risk, localized prostate cancer.

The Canadian-based company Profound Medical announced that they are weeks away from enrolling patients in a multijurisdictional clinical trial taking place in the U.S. and Europe for its MR-guided therapy for prostate cancer. Profound’s probe is unique in that it heats the prostate from inside to its boundary on the outside, as opposed to a trans-rectal application.

“Current techniques use a probe inserted into the rectum and heat across the rectal wall into the prostate and across the urethra into the other side,” says Steven Plymale, CEO of Profound. “Anatomically, we feel we have the advantage where we can more effectively reach our target a lot faster.”

The OR of the future?
While some FUS technology could be used in the urologist’s office — a shrink-wrapped ultrasound-guided version of the technology to treat prostate cancer for example — all experts interviewed for this story agreed that any MR-guided system should be portable with the ability to be used by many specialists in a health care setting.

InSightec envisions it as the “OR of the future,” and a strong competitor to traditional surgery.

“One big problem we face with all treatment is the cost of hospitalization. With this [technology] and prostate cancer for example, the procedure can be short, the patient goes to recovery room few hours and then goes home,” says Dr. Mark Schoenberg, chief medical officer at SonaCare Medical. He says he believes that technologies that will offer appropriately selected patients the opportunity to manage a cancer diagnosis with minimal collateral morbidity

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