Three generations of Sonablate HIFU equipment … the data from Japan

Over the weekend, one of our regular commentators brought to our attention a newly published, retrospective analysis of data on the risks and benefits of treatment of localized prostate cancer with three successive generations of high-intensity focused ultrasound (HIFU) equipment from the company now known as Sonocare Medical.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

Salvage LRP after failure of first-line HIFU: it’s feasible but …

Data from a very small study carried out by an Italian clinical research team has demonstrated exactly what one might expect … that salvage surgery can certainly be carried out for men in whom high-intensity focused ultrasound (HIFU) has failed, but that such salvage surgery comes with a higher morbidity rate than primary surgery.

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.

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.

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