Boston Scientific (NYSE: BSX) is resuming its “Avant Guard” study of pulse field ablation as a first-line therapy for persistent atrial fibrillation (AFib). The device developer paused the trial last month, with CEO Mike Mahoney citing the need to “assess a few unanticipated observations.” Boston Scientific said it did not halt the trial due to … [Read more...] about Boston Scientific resumes study of pulse field ablation as first-line AFib therapy
Boston Scientific
Boston Scientific to acquire Cortex and its cardiac mapping tech
Boston Scientific (NYSE: BSX) announced today that it will purchase Ajax Health's Cortex and its FDA-cleared OptiMap system to guide physicians performing ablation procedures to treat AFib Financial terms of the deal were not disclosed. Boston Scientific expects to complete the transaction in the first half of 2025, subject to customary closing … [Read more...] about Boston Scientific to acquire Cortex and its cardiac mapping tech
Boston Scientific warns on some PolarX cryoablation catheters following reports of death
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] issued an urgent field safety notice in Europe to notify customers of updates to its PolarX cryoablation catheters. Marlborough, Massachusetts-based Boston Scientific's notice relates to the PolarX and PolarX FIT cryoablation catheters. These systems work as part of the PolarX … [Read more...] about Boston Scientific warns on some PolarX cryoablation catheters following reports of death
FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval to expand the indication for its current-generation Ingevity+ pacing leads. The expanded indication includes conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when the pacing leads — thin wires placed … [Read more...] about FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’s Biosense Webster
Experts from Medtech Big 100 device developers — Medtronic, Johnson & Johnson MedTech, Abbott and Boston Scientific — discuss the various shapes of their pulsed field ablation (PFA) catheters. From flowers and loops to globes, baskets and balloons, there's no standard shape for the pulsed field ablation (PFA) catheters coming out of Medtronic, … [Read more...] about Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’s Biosense Webster
Bioabsorbable polymers for implantable medical devices: What to know
Bioabsorbable polymers are used for an expanding range of medical devices.
Bioabsorbable polymers degrade and disappear at predictable rates, making them an ideal material for parts of implantable devices that could otherwise impair healing or create an ongoing risk of injury or infection.
Bioabsorbable sutures made of glycolide/lactide polymers, first developed in the 1970s, are strong and flexible enough to hold … [Read more...] about Bioabsorbable polymers for implantable medical devices: What to know Bioabsorbable polymers are used for an expanding range of medical devices.
Boston Scientific has a serious recall involving embolization tech
The FDA announced today that it has designated a Boston Scientific recall of its Obsidio conformable embolic as Class I, its most serious level of recall. The Obsidio embolic is a premixed embolic agent that is delivered in a minimally invasive way through a catheter-based system. The embolic can block or occlude blood flow to specific blood … [Read more...] about Boston Scientific has a serious recall involving embolization tech
Boston Scientific begins trial of Faraview PFA software with magnetic nav catheter
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it began a new study of its Faraview software module for the Farawave pulsed field ablation (PFA) catheter. The NAVIGATE-PF study evaluates Faraview when used to visualize and track the Farawave Nav PFA catheter for treating AFib. Faraview and the Farawave … [Read more...] about Boston Scientific begins trial of Faraview PFA software with magnetic nav catheter
Boston Scientific has positive Agent DCB study results
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue … [Read more...] about Boston Scientific has positive Agent DCB study results
FDA approves Boston Scientific’s Agent drug coated balloon
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented … [Read more...] about FDA approves Boston Scientific’s Agent drug coated balloon
