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 […]
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 […]
FDA probes paclitaxel-eluting stents, balloons
The FDA wrote a letter to healthcare providers yesterday on the heels of a meta-analysis that suggested an increased mortality rate after two years in people with peripheral artery disease who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices. The agency is “evaluating” the new information presented by the study and recommended […]
Johnson & Johnson, Apple ink collab for AFib study
Johnson & Johnson‘s (NYSE:JNJ) Janssen and Apple (NSDQ:AAPL) said today that the two companies inked a deal to study if an app from J&J in combination with the Apple Watch’s ECG app and irregular rhythm notifications can improve outcomes for people living with atrial fibrillation. The study is slated to measure the impact of the Apple Watch […]
QT Vascular expands pivotal trial of Chocolate Touch DCB
QT Vascular said today that the FDA approved the company’s request to expand an on-going pivotal study of its Chocolate Touch drug-coated balloon to include the use of atherectomy for lesion preparation. The U.S. regulatory agency also approved the addition of subgroup analysis related to the use of atherectomy. The pivotal study of QT Vascular’s […]
Report: Medtronic, Boston Scientific stand by paclitaxel-eluting devices despite JAHA study
Major medtech players Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) continue to support the use of their paclitaxel-eluting devices in the legs after a study released last month indicated a link between the devices and an increased mortality rate, according to a Star Tribune report. In the meta-analysis, researchers led by Dr. Konstantinos Katsanos analyzed data from 28 […]
Reva brings bioresorbable scaffolds to new markets
Reva Medical (ASX:RVA) said this week that it inked four new distribution agreements, bringing its commercial operations to seven European countries. The San Diego, Calif.-based company said the deals serve to expand the reach of its drug-eluting bioresorbable scaffold, Fantom Encore. Reva said it landed deals with the following companies: A care a.s. in the Czech […]
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