The meta-analysis that suggested there was a link between paclitaxel-coated devices and heightened mortality compared to bare devices was described as a “typhoon in a teapot” at this year’s EuroPCR meeting, according to a report from MedScape. Dr. Alexandra Lansky of Yale University School of Medicine, who authored the organization’s formal statement on the matter, reportedly […]
FDA grants breakthrough nod to Concept Medical for MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of coronary in-stent restenosis. The device is cleared for treating patient’s who’ve experienced a re-narrowing of a stented coronary artery lesion due to subsequent tissue proliferation at the stented site, the Tampa, Fla.-based company […]
Cook Medical releases patient-level data from Zilver PTX paclitaxel-coated balloon study
Cook Medical said today that it is releasing de-identified patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent. The move comes only a month after the FDA said that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease […]
Surmodics ticks up on renewed SurVeil DCB trial enrollment
Surmodics (NSDQ:SRDX) shares have ticked up today after the company updated on the TRANSCEND clinical trial of its SurVeil drug-coated balloon, saying that it has resumed patient enrollment. Last month, the Eden Prairie, Minn.-based company paused enrollment after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease […]
Surmodics shares down following FDA’s paclitaxel device update
Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices. In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical […]
FDA updates docs on review of paclitaxel devices for PAD
The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices. In a letter to healthcare providers, the U.S. regulatory agency reported that there was […]
U.K., French regulators probe safety of paclitaxel devices
Taking a note from the FDA, U.K. and French regulators are investigating the safety of paclitaxel devices for the treatment of peripheral artery disease. Last week, the U.K. Medicines and Healthcare Products Agency said it ordered an inquiry into the safety of these devices following the publication of a meta-analysis that suggested a heightened risk […]
Medtronic updates on corrected safety analysis for paclitaxel-coated balloon
Medtronic (NYSE:MDT) said last week that a revised safety analysis of its In.Pact drug-coated balloon has been accepted by the Journal of the American College of Cardiology. Last month, the medtech titan reported that a programming error inadvertently caused mortality data to be omitted from a statistical analysis involving the company’s paclitaxel-coated balloon. The announcement came […]
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 […]
Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis
Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five […]
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