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 […]
FDA doubles down on warfarin test strip recall
The FDA this week alerted patients and doctors about test strips used to monitor levels of the blood thinner warfarin, expanding and reiterating its warning that the products shouldn’t be used to adjust a person’s drug dosage. The agency’s latest notice is related to the Class I recall of Roche‘s CoaguChek meters and test strips, […]
Reva Medical cuts 44% of workforce
Reva Medical (ASX:RVA) said this week that it plans to cut its workforce by 44%, leaving 22 employees at the San Deigo-based company. In a statement, Reva CEO Reggie Groves cited current market conditions as the primary reason for the staffing reduction. “While we continue to see strong interest in Fantom Encore and are excited about […]
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