The John Wayne Cancer Institute in Santa Monica, CA and Maimonides Medical Center in Brooklyn, NY were the first two hospitals to adopt EDAP TMS’ new Focal One device — an advanced ultrasound technology that can be used to target and ablate diseased tissue. Click here to read more about the Focal One device.EDAP TMS
FDA has ramped up medical device safety efforts in several areas this year. Most recently, the agency has turned its attention to devices designed to ablate prostate tissue.
The agency issued draft guidance Tuesday to provide recommendations for device manufacturers regarding the clinical testing that must be conducted in accordance with special controls for high-intensity ultrasound systems for prostate tissue ablation devices regulated under the agency’s 510(k) premarket notification program. This draft guidance also outlines recommended clinical data to support marketing submissions for prostatic tissue ablation devices that use newer, more innovative technologies or forms of energy to ablate (or destroy) prostate tissue.
“Devices that ablate or destroy prostate tissue require important safety and effectiveness data prior to marketing. As part of our continued commitment to aggressively addressing device safety while also encouraging innovation to provide patients with the safest and most effective treatment options, today we are providing recommendations on the type of clinical data manufacturers should include in their marketing submissions for prostate tissue ablation devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “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.”
For these types of prostate ablation devices, the FDA requires clinical testing to show that each new device addresses patient safety by demonstrating that the device does not ablate or damage tissue outside of the targeted area and that the device is as effective at ablating prostate tissue in the targeted area as a similar device with an equivalent safety profile.
Prior to initiating a clinical investigation for prostate tissue ablation devices, the FDA encourages manufacturers to contact the FDA with a Pre-Submission to obtain detailed feedback on the clinical investigation planned.
The scope of this draft guidance is limited to the clinical investigations to support marketing authorization for general indications of prostate tissue ablation systems. 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.
A recent example of this type of technology is the Focal One device from EDAP TMS, pictured above. The device uses advanced ultrasound technology to target and ablate diseased tissue.