Boston Scientific Touts Positive Data on Two Paclitaxel Devices

Boston Scientific announced positive data Tuesday for two paclitaxel devices during separate late-breaking clinical trial presentations at the annual Vascular InterVentional Advances (VIVA) meeting in Las Vegas. Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for the drug-coated balloon manufacturers and physicians this year, but presentations like these could go a long way toward helping the market rebound. To recap, paclitaxel balloons and stents received some bad press in late December 2018 after a meta-analysis showed an increased risk of death for patients treated with these devices. FDA held a two-day meeting of the Circulatory System Devices Panel in June, and concluded at the meeting that there is a signal associated with an increase in mortality through five years of paclitaxel-coated (or eluting) devices compared to non-coated devices. The agency was not, however, able to attribute this increased risk to a specific cause, and the committee was befuddled by data discrepancies. FDA eased up on recommendations regarding paclitaxel devices in August, but by that time the issue had already driven a market decline of about 50%.   Good News for Eluvia Data presented this week at VIVA included a 12-month interim analysis from the RANGER II SFA trial of the Ranger drug-coated balloon (DCB) as well as 24-month results from the ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news