Tag: Boston Scientific

Boston Scientific Announces LOTUS Edge™ Aortic Valve System Voluntary Recall and Product Discontinuation

MARLBOROUGH, Mass., Nov. 17, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) has announced it has initiated a global, voluntary recall of all unused inventory of the LOTUS Edge™ Aortic Valve System due to complexities associated with the product delivery system. The voluntary recall […]

Boston Scientific Initiates Trial to Evaluate WATCHMAN FLX™ Left Atrial Appendage Closure Device as First-Line Treatment for People at Risk of Stroke

Trial to study next-generation device as treatment alternative to NOACs for broader population of patients with non-valvular atrial fibrillation MARLBOROUGH, Mass., Oct. 29, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) has initiated the CHAMPION-AF clinical trial to evaluate the safety and efficacy […]

Boston Scientific Launches ACURATE neo2™ Aortic Valve System in Europe

Next-generation Valve Designed to Reduce Paravalvular Leaking, Improve Procedural Efficiency and Treat More Patients with Expanded Indication over Prior Version MARLBOROUGH, Mass., Sept. 28, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has initiated a controlled launch of the ACURATE neo2™ Aortic […]

Boston Scientific Announces Expanded Investment and Exclusive Acquisition Option Agreement with Farapulse, Inc.

Agreement expands company’s access to pulsed field ablation technology MARLBOROUGH, Mass., Sept. 21, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has signed an investment agreement with an exclusive option to acquire Farapulse, Inc., a privately-held company developing a pulsed […]

Boston Scientific Receives FDA Approval for Next-Generation WATCHMAN FLX™ Left Atrial Appendage Closure Device

New stroke risk reduction technology designed to advance procedural performance and safety, treat wider range of patients with non-valvular atrial fibrillation MARLBOROUGH, Mass., July 21, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval […]

Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx™ Insertable Cardiac Monitor System

First ICM device with remote programming paired with dual-stage arrhythmia detection algorithm MARLBOROUGH, Mass., June 29, 2020 /PRNewswire/ — Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, a new, long-term […]