New Indications for DrugCoated Balloons FDA View Eleni
New Indications for Drug-Coated Balloons – FDA View Eleni Whatley Peripheral Interventional Devices Branch FDA
Eleni Whatley, Ph. D I have no relevant financial relationships
Current Landscape • Drug-Coated Balloons (DCBs) that are approved in the US are currently indicated for the superficial femoral artery (SFA) and arteriovenous fistula (AVF) • Indications for some DCBs approved for the SFA have been expanded to include in-stent restenosis (ISR) and long lesions
Indications Expansions • As for other device areas, the amount and type of evidence that should be submitted in order to support an indications expansion will depend on the significance of the expansion and its potential to affect the safety and effectiveness of the device when used according to its new indications for use • Examples: – New anatomy – Different lesion/vessel characteristics
“Minor” Indications Expansions • “Minor” indications expansions, such as those that are very similar to that of the approved indication, may not require as much or as robust evidence as a completely new indication – Example: same vasculature but new lesion/vessel characteristics (ISR lesions or longer lesions) Leverage most non-clinical testing with new clinical data • FDA may accept alternative, least burdensome approaches when considering these indications expansions, including lower sample sizes, single-arm studies, and the use of real world evidence (RWE), when appropriate – PIDB has recently expanded the indications for use to include ISR and/or long lesions for 2 DCB manufacturers using limited RWE
“Significant” Changes • FDA considers indications expansions that are in completely new vasculatures to be more significant and, therefore, more robust data should be submitted to support the safety and effectiveness of this device – Examples: coronary arteries, below-the-knee – The patient demographics, lesion characteristics, and underlying disease are typically different for these vasculatures, which may result in different safety and effectiveness outcomes • Significant design or material/drug changes may also require additional clinical data to support safety and effectiveness – Example: new coating (e. g. , API, excipient, drug dose), novel features
Coronary and BTK Indications • In order to pursue a coronary or BTK indication for a DCB, FDA recommends conducting an RCT as compared to the current gold standard of care (or other appropriate comparator) • Given uncertainties of treatment for these vasculatures, FDA does not believe that a performance goal based approach is appropriate at this time – Due to the numerous known and unknown covariates and the evolving and wide-range clinical practice
Coronary and BTK Indications • The trial design, including endpoints and time points, will depend on the specific indication for use that is being considered • FDA recommends submitting a Pre-submission to discuss device evaluation strategy and clinical trial design
Eleni. whatley@fda. hhs. gov
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