Piper sees minimal impact from FDA review of paclitaxel coated devices

The FDA on Friday afternoon updated healthcare providers on its review of paclitaxel coated devices, which include Medtronic’s (MDT) IN.PACT DCB and Boston Scientific’s (BSX) Eluvia DES, Piper Jaffray analyst Matt O’Brien tells investors in a research note. In their pooled post-approval analysis, the FDA found ~50% increased risk of crude mortality compared to control devices and will be convening a panel to analyze this issue further, adds the analyst. He points out that the FDA is also recommending providers monitor patients who have received the devices and encouraging these providers to consider alternatives where the risks may outweigh the benefits. While this data is concerning, the result is “unsurprising given that many of these patients were included in the meta-analysis,” contends O’Brien. Further, experts at the ISET 2019 conference in January were unconvinced about this connection to mortality, and a poll of the several hundred interventionists in the room indicated that it is unlikely to dampen usage in the interim, he says. As such, the analyst expects the FDA impact to have a minimal impact.

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