Guest guest Posted April 28, 2004 Report Share Posted April 28, 2004 InSightec ExAblate 2000 Non-Invasive Uterine Fibroid Treatment Gets June 3 Panel Review InSightec's premarket approval application for the ExAblate 2000 system to treat uterine fibroids non-invasively will be reviewed by FDA's Obstetrics & Gynecology Devices Panel June 3. The panel will review data from the firm's randomized, controlled trial comparing hysterectomy with focused ultrasound using ExAblate. The international study enrolled 109 patients in the test arm and 86 in the control arm, InSightec says. read the rest here: http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Device+Pane\ ls/060304_ExAblate/060304_ExAblateA.htm Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 31, 2004 Report Share Posted May 31, 2004 , Reviewing email from the past month...I neglected to respond publicly to this query of yours re: focused ultrasound. The answer: they didn't. The FDA story is inaccurate. Kinda scary thinking that the FDA has control over approving a device when they can't even seem to get the basic IDE info correct on the Phase III clinical trial for this. The media has been calling all week over the pending story of FDA review of Insightec's HIFUS. Oh boy. I can hardly wait for the additional 'marketing disguised as news' to hit the stands. The toll free phone number for NUFF has been temporarily disconnected. We cannot afford another round of toll-free (free to the consumer--not free to NUFF) telephone onslaught of financial doom as that generated by Insightec last Mother's Day in May 2003 when the story they helped with was published in USA Today. Sorry, but I simply had to do this. The media calls (this past week) on this story were a wake-up call to me that this could completely shut NUFF down and put us out of business. Ugh. Sure would like to see some long term results on this treatment...hell, gyns and patients alike backed IRs into the corner of a Fibroid Registry and publishing a multitude of papers on outcome prior to giving it the thumbs up for patients. Can't seem to quite understand why HIFUS is getting a pass on ALL of this. Nine papers published to date on HIFUS and fibroids: 4 animal studies, 4 early investigative studies on the technology, and 1 human study--the Phase II study done at Brigham's. Criminy. No way in hell the FDA allowed UAE a 'pass' -- so why are they potentially giving a 'pass' on HIFUS based on this limited body of study? It's an interesting question, don't you think? Unplugging the phone and going on vacation here...til the tidal wave of media passes on this one...I have nothing kind to say...so best not to say it at all... Carla > >Message: 7 > > Date: Wed, 28 Apr 2004 12:29:53 -0000 > > From: " Carla Dionne " > >Subject: HIFUS > > > >InSightec ExAblate 2000 Non-Invasive Uterine Fibroid Treatment Gets > >June 3 Panel Review > > > >InSightec's premarket approval application for the ExAblate 2000 > >system to treat uterine fibroids non-invasively will be reviewed by > >FDA's Obstetrics & Gynecology Devices Panel June 3. > > > >The panel will review data from the firm's randomized, controlled > >trial comparing hysterectomy with focused ultrasound using ExAblate. > >The international study enrolled 109 patients in the test arm and 86 > >in the control arm, InSightec says. > > > >read the rest here: > >http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Device+Pan\ els/060304_ExAblate/060304_ExAblateA.htm > > Quote Link to comment Share on other sites More sharing options...
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