HIFU FDA Application Stalled For Now

FDA Panel Doesn’t Recommend Device To Help Treat Recurrent Prostate Cancer.
Medscape (10/3) reports and FDA advisory committee voted Oct. 1 “not to recommend approval, at least for now, of a high-intensity focused ultrasound (HIFU) device to treat some patients with recurrent prostate cancer.” The piece notes that the members of the Gastroenterology and Urology Devices Panel of the FDA’s Medical Devices Advisory Committee “encouraged the device manufacturer to continue to conduct research” but to return “when the ongoing pivotal trial at 20 sites” in the US and Canada is completed, “not halfway through.” SonaCare Medical Devices of Charlotte, NC, is seeking FDA approval of its Sonablate 450, “a computer-controlled device with a probe that clinicians can use to deliver HIFU energy through thermal ablation to the prostate.”

The background story: I was there at the deliberations and testified to the FDA Advisory Panel in favor of approval. The FDA Panel Review presentation and my testimony went well, but I was disappointed to find Pat Walsh from Johns Hopkins the leader of the academic panel advising the FDA. He is one the leading opponents of HIFU in spite of never having seen one. He hates radiation and Cryo therapy too. He only likes radical prostatectomy and seems to think he’s the only one who knows how to do it. He and the rest of the panel spent all morning praising the presentation and testimonies, then he went to work during the afternoon. They couldn’t fault the study, so he (and then many of the rest of the panel advising the FDA) decided 1 year of followup was not long enough. They suggested minimum 5 years, whereupon the chief of the FDA yelled at them saying they could not just arbitrarily change the study parameters. They then dug in their heels and did not vote to support approval without longer followup. So now the FDA is in a bit of a pickle. They are hesitant to approve w/o support of the panel, but there is no reason to not approve the study as performed. Technically the FDA could be sued, as SonaCare has spent over $20 million on the study so far, and the 1 year followup was set by the FDA, not SonaCare (remember the PSA usually bottoms out within 3-6 months). My personal prediction is that they will tell SonaCare to do the second half of the study (remember FDA invited the company to present after 100 patients instead of 200), then come back. Seems the only reasonable way for FDA to save face. They are hesitant to buck the academics on the panel, because if the device had after-market complications, they would be criticized for moving too fast. They have 90 days to make their decision. So for now, I’m still commuting to Mexico.