FDA Draft Guidance on Prostate Tissue Ablation Devices Garners Support
Industry trade associations made the case for revisions to draft guidance on clinical testing recommendations for prostate tissue ablation devices in comments earlier this month.The Medical Imaging & Technology Alliance (MITA) and AdvaMed touted the details of the US Food and Drug Administration (FDA) draft guidance, issued in June, to aid in the collection of clinical data to demonstrate the safety and effectiveness of prostate tissue ablation devices that use different sources of energy for the destruction or removal of harmful prostate tissue. The groups’ calls to fine-tune certain portions of the draft guidance come in support of such efforts.
MITA Executive Director Patrick Hope says the group expects “more prostate ablation and focused ultrasound products to be released in the coming years, making it important to create a strong guidance about prostate ablation devices to serve as a model for future focused ultrasound devices.” The group’s comments thus seek to help the final version of the draft guidance to provide manufacturers a “valuable tool in developing their clinical investigations.”
But both MITA and AdvaMed caution against how the draft guidance proposes to recommend reporting effectiveness endpoints. The groups seek alignment on a general indication for the ablation of prostate tissue.
“We don’t believe that requiring one type of effectiveness endpoint (ex: biopsy) should be the recommendation because other alternatives are just as effective at measuring the extent of ablation such as post-ablation MRI imaging, especially when the ablation is subtotal,” says Hope. Tara Federici, AdvaMed vice president of technology and regulatory affairs, adds that “requiring endpoints that may be considered specific for malignancy may not be appropriate.”
AdvaMed suggests revisions that target recommendations on datasets and the minimum duration of scheduled follow-up for studies to support a premarket submission. FDA should allow additional dataset sizes based on clinically relevant information and strike the one-year minimum duration of scheduled follow-up. “Adverse events do not follow a linear progression and should be based on a clinically relevant time point,” notes Federici. “Depending on the type of prostate ablation being used the adverse event profile may differ in onset and duration.”
MITA takes issue with internally controlled trials, also. “Such trials are extremely expensive, are difficult to achieve adequate recruitment numbers in the comparator arms, and rarely, if ever, are performed successfully, especially with ‘standard of care’ therapies,” Hope adds.
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