Boston Scientific Corporation (NYSE:BSX) agreed to acquire Bolt Medical, Inc., the developer of an intravascular lithotripsy ...

Get Monthly Picks of Market's Fastest Movers Boston Scientific is updating use instructions for POLARx Cryoablation Balloon Catheters due to a higher than anticipated number of reports of ...

Boston Scientific has updated the instructions for its Polarx and Polarx FIT cryoablation balloon catheters, the Food and Drug Administration said Wednesday. The update followed a higher than ...

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 Bolt IVL system is designed to use lithotripsy to fracture calcium by creating acoustic pressure waves inside a balloon catheter ... Updates Instructions for Cryoablation Balloons After ...

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 ...

During a cryoablation procedure, a balloon expands inside the pulmonary ... Seven reports of injuries and four fatalities are linked to the catheters. The FDA has classified the instruction ...

The recall involves updating instructions for use rather than removing the device, POLARx Cryoablation Balloon Catheters, from where they are used or sold, the FDA said. The company meanwhile is ...

Boston Scientific has updated the instructions for its Polarx and Polarx FIT cryoablation balloon catheters, the Food and Drug Administration said Wednesday. The update followed a higher than expected ...