Boston Scientific (NYSE:BSX) has issued a correction recall for its POLARx and POLARx FIT cryoablation balloon catheters over ...
The U.S. Food and Drug Administration on Wednesday classified a recall of Boston Scientific's catheters used in a type of ...
The Scoring Balloon Catheter NSE Alpha is designed for precise dilatation across a wide range of lesion types. NSE Alpha has three scoring elements for a controlled scoring of the vessel wall and ...
Drug-coated balloon catheters are specialized medical devices used primarily for expanding narrowed coronary arteries by delivering drugs during the dilation process, aimed at preventing restenosis ...
The update followed a higher than expected number of reports of esophageal injury after catheter ablation procedures for ...
The FDA is elevating a recall from Boston Scientific covering its cryoablation balloon catheters for the treatment of atrial ...
The other lumen has a valve on the outside end and connects to a balloon at the tip; the balloon is inflated with sterile water when it lies inside the bladder, and allows for retention in the bladder ...
Devices already in inventory can be used with the updated instructions by doctors. Patients already treated don’t need to do ...
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.
The global interventional cardiology devices market, valued at US$26.32 billion in 2023, is forecasted to grow at a robust ...
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 ...