FDA wants tighter control of certain prostate ablation devices
The FDA appears poised to impose a tougher clearance process on manufacturers of high-intensity ultrasound systems for prostate tissue ablation.
The agency has issued new draft guidance on clinical testing that manufacturers of these devices must conduct, in accordance with special controls. The draft guidance also outlines recommended clinical data to support 510(k) applications for such devices that use newer, more innovative technologies or forms of energy to ablate (or destroy) prostate tissue.
Manufacturers would have to include at least 100 patients in their clinical studies. Results must show that the device does not destroy or damage tissue outside of the targeted area and that it is as effective at ablating prostate tissue in the targeted area as a similar device with an equivalent safety profile. The agency would require a follow-up study of at least one year.
This draft guidance does not address the clinical investigations of devices that are intended to treat specific prostatic diseases, such as prostate cancer or benign prostatic hyperplasia. Disease-specific studies use different endpoints and study designs to demonstrate safety and effectiveness compared to a study to demonstrate effective tissue ablation, the agency said.
“Devices that ablate or destroy prostate tissue require important safety and effectiveness data prior to marketing,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release. “Our proposal highlights the use of clinical evidence under the 510(k) premarket notification program. This guidance also advances both safety and innovation by clarifying the clinical evidence that would support new and safe ways to destroy prostate tissue such as ultrasound or alternative technologies. By doing so, we can help give patients access to safer, more effective devices than they had even a few years ago.”
“Known probable adverse events” resulting from high-intensity ultrasound prostate tissue ablation include urethral stricture, rectal fistula, and osteomyelitis pubis, the agency said.