Boston Scientific updates cryoablation catheter instructions after 4 death reports - Yahoo Finance

Boston Scientific won FDA approval in August 2023, establishing the Polarx system as a challenger to cryoablation technology sold by Medtronic. Polarx has been available in Europe since 2020. Read More

Boston Sci issues safety recall for POLARx cryoablation catheters - MSN

Boston Scientific (NYSE:BSX) has issued a correction recall for its POLARx and POLARx FIT cryoablation balloon catheters over concerns that they may cause serious esophageal injuries or even death. Read More

Boston Scientific recalls catheters following 4 reported deaths - Becker's Hospital Review | Healthcare News & Analysis

Boston Scientific has issued a recall for its POLARx Cryoablation Balloon Catheters after four deaths and seven reported injuries linked to astrio-esophageal fistulas, a severe complication during ... Read More

Boston Scientific Updates Instructions for Cryoablation Balloons After Reports Of Severe Injuries - Boston Scientific (NYSE:BSX) - Benzinga

On Wednesday, Boston Scientific Corporation BSX revised the usage guidelines for its Polarx and Polarx FIT cryoablation balloon catheters following reports of serious injuries, including seven ... Read More

Boston Scientific catheters treating AFib with extreme cooling linked to 4 deaths: FDA alert - Star Tribune

Boston Scientific has updated its instructions for doctors using catheter technology to treat atrial fibrillation with extreme cooling, following reports of four fatalities and other serious ... Read More

FDA classifies recall of Boston Scientific catheters as 'most serious'

Dec 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday classified a recall of Boston Scientific's (BSX.N), opens new tab catheters used in a type of minimally invasive surgery as ... Read More

FDA elevates Boston Scientific cryoablation correction effort following four deaths

The FDA is elevating a recall from Boston Scientific covering its cryoablation balloon catheters for the treatment of atrial fibrillation. No hardware is being removed from use—instead, the ... Read More

Boston Scientific's (BSX) POLARx System Gets FDA Approval

Boston Scientific's (BSX) POLARx enables doctors to expand and modify the new POLARx catheter to match a patient's unique anatomy during an ablation treatment. Read More

FDA approves Boston Scientific’s afib-freezing catheter - Fierce Biotech

Boston Scientific earns FDA approval for afib-freezing cryo catheter By Andrea Park Aug 9, 2023 10:53am Boston Scientific ablation atrial fibrillation balloon catheters ... Read More

Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

First-of-its-kind expandable cryoballoon catheter advances cryoablation therapy, addresses key limitations with traditional systems MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston ... Read More

Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx ... Read More