Boston Scientific recalled and discontinued all Imager II angiographic catheters due to a manufacturing issue, according to an FDA early alert. Imager II angiographic catheters are diagnostic intravascular catheters used to capture images of the patient’s peripheral vasculature. Boston Scientific determined the catheters were “manufactured … [Read more...] about Boston Scientific discontinues Imager II angiographic catheter sales
Boston Scientific
FDA warns on percutaneous catheter issue from Boston Scientific
The FDA today issued an early notice after Boston Scientific (NYSE:BSX) recommended the removal of certain percutaneous catheter systems. In a letter dated July 9, 2026, Boston Scientific told customers to identify affected EnRoute transcarotid neuroprotection system (NPS) and EnRoute NPS Plus products and cease use and distribution. Customers … [Read more...] about FDA warns on percutaneous catheter issue from Boston Scientific
Boston Scientific enrolls first patient in FARADIGM IDE trial for Faraflex PFA system
A Boston Scientific (NYSE:BSX) executive said today that the company enrolled the first patients in a new pulsed field ablation (PFA) trial. Nick Spadea-Anello, Boston Scientific EVP and president of Electrophysiology, shared the news of the initial enrollments on LinkedIn. Dr. Andrea Natale and the Texas Cardiac Arrhythmia Research team at St. … [Read more...] about Boston Scientific enrolls first patient in FARADIGM IDE trial for Faraflex PFA system
Boston Scientific study of Seismiq coronary IVL meets endpoints
Boston Scientific (NYSE:BSX) today reported positive results from the FRACTURE study of its Seismiq intravascular lithotripsy (IVL) catheter. The pivotal FDA investigational device exemption (IDE) trial evaluates the use of the Seismiq 4CE coronary IVL catheter in the treatment of patients with severely calcified coronary artery disease … [Read more...] about Boston Scientific study of Seismiq coronary IVL meets endpoints
Boston Scientific treats first patient with Seismiq IVL in ELEGANCE registry
Boston Scientific (NYSE:BSX) today announced the first patient treated with its Seismiq IVL system in the ELEGANCE registry. Dr. Michael R. Jaff, chief medical officer and VP of Peripheral Interventions at Boston Scientific, shared the news of the first IVL (intravascular lithotripsy) patient treated in the registry on LinkedIn. The ELEGANCE … [Read more...] about Boston Scientific treats first patient with Seismiq IVL in ELEGANCE registry
Boston Scientific studies back Farawave, Faraflex, Watchman FLX Pro and more
Boston Scientific (NYSE:BSX) today shared new clinical findings supporting its wide-ranging electrophysiology (EP) portfolio. The Marlborough, Massachusetts-based company shared its findings, covering pulsed field ablation (PFA) and combined approaches with left atrial appendage closure (LAAC) to treat AFib, reduce stroke risk and support … [Read more...] about Boston Scientific studies back Farawave, Faraflex, Watchman FLX Pro and more
Johnson & Johnson launches head-to-head PFA trial pitting Varipulse against Boston Scientific’s Farapulse
Johnson & Johnson (NYSE:JNJ) today announced the initiation of a new trial evaluating competitive pulsed field ablation (PFA) technologies. The PERSIGMA RCT pits the company's Varipulse Pro PFA platform against the Boston Scientific Farapulse system. It compares the two leading PFA therapies in treating persistent AFib. Varipulse Pro, which … [Read more...] about Johnson & Johnson launches head-to-head PFA trial pitting Varipulse against Boston Scientific’s Farapulse
Boston Scientific reports positive findings for Ekos endovascular system in pulmonary embolism
Boston Scientific (NYSE:BSX) announced positive data from a randomized clinical trial evaluating its EKOS endovascular system. EKOS provides minimally invasive, ultrasound-facilitated, catheter-directed thrombolysis (USCDT). It delivers a low dose of clot-dissolving medication directly to the blood clot, using ultrasound energy to facilitate the … [Read more...] about Boston Scientific reports positive findings for Ekos endovascular system in pulmonary embolism
Boston Scientific wins expanded CE mark for Farapulse in persistent AFib
Boston Scientific (NYSE: BSX) announced today that its Farapulse pulsed field ablation (PFA) system received expanded CE mark approval. The PFA system earned expanded labeling in Europe to include the treatment of persistent AFib, according to a LinkedIn post. "This approval represents an important step forward in addressing the evolving … [Read more...] about Boston Scientific wins expanded CE mark for Farapulse in persistent AFib
AHA, ACC issue guidelines for pulmonary embolism that affect Boston Scientific, Stryker
New guidelines related to pulmonary embolism could provide a boost for Boston Scientific (NYSE: BSX) and Stryker (NYSE: SYK), among others. Yesterday, the American Heart Association (AHA) and American College of Cardiology (ACC) joint committee updated its guidelines for pulmonary embolism (PE). This marks the first update since the AHA last … [Read more...] about AHA, ACC issue guidelines for pulmonary embolism that affect Boston Scientific, Stryker
