UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared […]
Soligenix soars on COVID-19 vaccine licensing agreement with Boston Scientific
Soligenix (NSDQ:SNGX) skyrocketed up 89% in premarket trading this morning after announcing today that it entered into an exclusive worldwide licensing agreement with Boston Scientific (NYSE:BSX) for its CoVaccine HT novel vaccine adjuvant for COVID-19. Shares of SNGX were up 12.5% at $1.58 per share in mid-morning trading today as well. Boston Scientific’s BTG Specialty Pharmaceuticals […]
Study: High- and low-dose drug-coated balloons equally effective in PAD
A Boston Scientific (NYSE:BSX) device coated with less of the controversial drug paclitaxel than one made by Medtronic (NYSE:MDT) is just as safe and effective for patients with peripheral artery disease (PAD), according to a study published this week. The prospective, randomized controlled trial compared the lower-dose (2 μg/mm2 of paclitaxel) Boston Scientific Ranger drug-coated […]
Study: No difference between Biotronik, Medtronic or Boston Scientific stents
A study comparing drug-eluting stents made by Biotronik, Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) found no statistically significant difference on target vessel failure or stent thrombosis after three years. The 3,514-patient Bio-Resort trial compared Biotronik’s Orsiro biodegradable sirolimus-eluting stent, Medtronic’s thin-strut zotarolimus-eluting Resolute Integrity stent and the Synergy biodegradable everolimus-eluting stent. Three-year results for some 3,393 […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]
FDA: More data needed on paclitaxel devices
More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today. A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons […]
Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent
The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people […]
Docs plan industry collab to study paclitaxel devices
Non-for-profit org Viva Physicians said yesterday that it will lead a pan-industry effort to study the use of paclitaxel-eluting devices for the treatment of peripheral artery disease in above-the-knee applications. The initiative comes on the heels of a meta-analysis published in the Journal of the American Heart Association this month showing a potential link between […]
LINC 2019: Medtronic, Boston Scientific back paclitaxel devices amid safety probe
Amid concerns about a potential link between paclitaxel devices and heightened long-term mortality rates, Medtronic (NYSE:MDT) and other device-makers doubled down on their products’ safety at this year’s Leipzig Interventional Course in Germany. Medtronic presented a patient-level survival analysis that included 1,837 patients enrolled in its In.Pact Admiral clinical program. The analysis assessed all-cause mortality across […]
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