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
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
Boston Scientific warns on fragment embolization in some PolarSheath devices
Boston Scientific has issued an urgent field safety notice for some of its PolarSheath steerable sheaths due to the risk of embolization. The company is removing specific batches of PolarSheath steerable sheaths due to a tooling error in manufacturing, which may have caused delimitation of the inner lumen of the sheath shaft in a subset of … [Read more...] about Boston Scientific warns on fragment embolization in some PolarSheath devices
Catheter design was key for the Boston Scientific Farapulse pulsed field ablation system
Boston Scientific Chief Medical Officer Dr. Ken Stein explains how catheter design drives the Farapulse pulsed field ablation system.
Following FDA approval on Jan. 31, Farapulse from Boston Scientific is now the second pulsed field ablation (PFA) system approved to treat atrial fibrillation (AFib) in the U.S.
Medtronic’s PulseSelect PFA System picked up the first FDA approval in December for the treatment of paroxysmal and persistent AFib.
Boston Scientific’s Farapulse, on … [Read more...] about Catheter design was key for the Boston Scientific Farapulse pulsed field ablation system
Boston Scientific shares positive drug-coated balloon data
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced positive data from a trial of its Agent drug-coated balloon (DCB). The Marlborough, Massachusetts-based company presented its results at the Transcatheter Cardiovascular Therapeutics (TCT) meeting. Data demonstrated statistical superiority for Agent compared to … [Read more...] about Boston Scientific shares positive drug-coated balloon data
The biggest cardiovascular stories from TCT 2023
Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT. This year's 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco. Usual suspects like Medtronic and Abbott had data on display for a range of products, while other big … [Read more...] about The biggest cardiovascular stories from TCT 2023
Boston Scientific’s Dr. Michael Jaff on the future of peripheral intervention
Advanced technologies have the potential to take peripheral therapy "to a different stratosphere," says Dr. Michael Jaff, the chief medical officer and VP of the Boston Scientific Peripheral Interventions business. He characterized them as similar to the ability to combine devices with drugs, which he called the biggest transformational change … [Read more...] about Boston Scientific’s Dr. Michael Jaff on the future of peripheral intervention
FDA approves next-gen Watchman FLX Pro from Boston Scientific
A string of positive news continues for Boston Scientific (NYSE: BSX), which this week announced FDA approval for its next-generation Watchman FLX. Last week, the company reported positive data for its Farapulse system, which led to a favorable reaction from analysts and the market. Just the week before, Boston Scientific received expanded FDA … [Read more...] about FDA approves next-gen Watchman FLX Pro from Boston Scientific