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HIFU Treatment Receives FDA Approval

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Prostate Cancer
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Posted 10/17/2015 7:22 PM (GMT 0)
I just saw this link posted on another site, and thought that it also belongs here.

HIFU has been used in other countries for years, but was under a lengthy study process in the USA, which apparently it has now passed.

Another option to look at when deciding a course of action for treating prostate cancer.

http://www.urotoday.com/2014-09-18-02-47-34/prostate-cancer/84004-fda-approves-first-focused-ultrasound-system-for-treating-the-prostate.html
Posted 10/18/2015 12:42 AM (GMT 0)
I read a commentary on the FDA approval. That writer stated that the two manufacturers had been trying to get approval for eleven years, but could not satisfy the volume of patient data that the FDA wanted to see. So, a few months ago, one of the companies submitted a different application asking that their machine be certified for removing prostate tissue. It was.

So, that means that the machine was approved as a type of surgical knife, but did not address its effectiveness for cancer. Now, of course, because the process is "approved" for removing all prostatic tissue, that includes cancer. So, yes, there is more legitimacy in using the device and process, but the patient has no more assurance of long term outcome than before.
Posted 10/18/2015 3:47 PM (GMT 0)
My urologist is a proponent of the procedure and I had looked into it when I was dx'd the beginning of this year.

The European studies I looked at did not show overwhelmingly great results. That combined with the necessity to treat out of the US, no assurance of insurance reimbursement, time to be spent with the catheter, etc. led me away from it. Conceivably, I might have decided differently if I had been willing to treat in a focused, rather than whole gland method. Would have at least looked at it more seriously with US availability and insurance reimbursement.
Posted 10/18/2015 8:52 PM (GMT 0)
Having had HIFU almost 6 years ago I'm glad to see it is going to be available in the USA. There are risks involved as with any of the procedures trying to eliminate prostate cancer. But for me it was the best option and I have no regrets.
Posted 10/20/2015 1:07 AM (GMT 0)
Wonder how long it will take to get approved for payment by Medicare?
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