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 ...
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Boston Scientific catheters treating AFib with extreme cooling linked to 4 deaths: FDA alertBoston Scientific has updated its instructions for doctors using catheter technology to ... through blood vessels. During a cryoablation procedure, a balloon expands inside the pulmonary vein ...
A 7-Fr 6-mm-tip CRYO catheter (Freezor Xtra, Cryocath Technologies) was used. The procedure was performed under local anesthesia (2% lignocaine) without sedation. Cryomapping was carried out at ...
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, ...
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Boston Sci issues safety recall for POLARx cryoablation cathetersBoston 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 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 ...
Twenty patients (eight males, age 46.5 ± 12.5 years) diagnosed with AVNRT were randomized to receive CRYO (11) with a 6-mm-tip catheter or RF (nine) with a 4-mm-tip catheter. Patients' pain ...
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