FDA has questions about Ablatherm HIFU device

According to a report on the Bloomberg News web site, the FDA’s reviewers appear to be less than enthusiastic about the effectiveness and safety data submitted by EDAP TMS to support approval of the Ablatherm device for use of high-intensity focused ultrasound (HIFU) for the treatment of low-risk forms of prostate cancer. … READ MORE …

FDA schedules meetings to review PMAs for Ablatherm’s, SonoCare’s HIFU devices

According to a media release issued earlier today by EDAP TMS, the U.S. Food and Drug Administration (FDA) has scheduled a meeting on July 30, 2014, to review the Pre-Market Approval (PMA) application for EDAP’s Ablatherm-HIFU device for the treatment of localized prostate cancer. … READ MORE …

Outcomes after first-line and repeat HIFU procedures in the UK

In the UK, the team led by Drs Ahmed and Emberton has been meticulous in its collection and reporting of outcome data related to their investigational use of high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer. … READ MORE …

Morbidity associated with HIFU at three UK academic centers

A group of three centers in the UK has been investigating the appropriate use of high-intensity focused ultrasound (HIFU) since 2004. … READ MORE …

8-year bPFS data for 1,000+ French HIFU patients

A French clinical research group has just reported 8-year biochemical progression-free survival (bPFS) data for > 1,000 men with localized prostate cancer treated with first-line high-intensity focused ultrasound (HIFU). We assume that these data were generated using the Ablatherm HIFU technology. … READ MORE …

Ablatherm HIFU data on 5,000+ patients with T1 to T3 localized prostate cancer

Another paper to be presented at the upcoming annual meeting of the American Urological Association (AUA) offers us some additional data on the effectiveness and safety of high-intensity focused ultrasound (HIFU) carried out using the Ablatherm technology and recorded in the @-Registry database. … READ MORE …

Ablatherm HIFU data on low-risk patients from the @-Registry

A new study to be presented at the upcoming annual meeting of the American Urological Association in San Diego will provide data on the first-line treatment of some 358 men with low-risk prostate cancer collected in the @-Registry, all of whom received treatment with high-intensity focused ultrasound (HIFU) using the Ablatherm® form of this technology. … READ MORE …

Finally … Some real 5-year outcome data on HIFU, but were the right patients being treated?

“Medium term outcomes” data following first-line treatment with high-intensity ultrasound (HIFU) are to be presented at the upcoming annual meeting of the American Urological Association. … READ MORE …

US FDA accepts data filing for Ablatherm HIFU technology

According to a media release issued by EDAP TMS SA yesterday, the U.S. Food & Drug Administration (FDA) has issued a positive Filing Review Notification to the company with respect to EDAP TMS’s Pre-Market Approval (PMA) application for its Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound) device. … READ MORE …

HIFU outcomes in Germany after an average of 8 years of follow-up

Researchers at the University of Regensburg in Germany have just reported progression-free survival data from their 14-year experience of using high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer. This research group was one of the first to start testing the use of HIFU in the treatment of prostate cancer. … READ MORE …

EDAP TMS submits data for approval of HIFU to US FDA

We understand from media reports that the French medical device company EDAP TMS has submitted documentation to the U.S. Food & Drug Administration (FDA) for pre-market approval of their Ablatherm technology for treatment of low-risk, localized prostate cancer with high-intensity, focused ultrasound (HIFU). … READ MORE …

NICE publishes guidance on focal HIFU for the treatment of localized prostate cancer in UK

In the UK, the National Institute for Clinical Excellence (NICE) has just published guidance on the use of focal forms of high-intensity focused ultrasound (HIFU) for the treatment of (low- and intermediate-risk forms of) localized prostate cancer. … READ MORE …

4-year bPFS in a series of 400+ Canadian men treated with first-line HIFU

We finally appear to have mid-term follow-up data from a sizeable series of North American patients with low- and intermediate-risk prostate cancer treated with first-line, high-intensity focused ultrasound (HIFU). The follow-up is limited to a median of 2 years, however, which allows projection of outcomes at 4 years. … READ MORE …

Focal HIFU in men with localized prostate cancer — data from a small, initial, UK trial

A report just published on line in The Lancet Oncology provides data from a study of the use of focally directed (as opposed to whole gland) high-intensity focused ultrasound (HIFU) in the treatment of a small series of men with localized prostate cancer between 2007 and 2010. The data are interesting but follow-up to date is short. … READ MORE …

The management of recurrent prostate cancer after first-line therapy

Traditionally, men with prostate cancer who had recurrent disease after first-line surgery or first-line radiation therapy had a limited number of treatment options, but we are now seeing a significant expansion in the range of options available (although limited data are as yet available to support the effectiveness of nearly all these options). … READ MORE …

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