Boston Scientific Updates Catheter Instructions After 4 Deaths Linked to Cryoablation Procedures

DIVE BRIEF Summary: Boston Scientific has revised the instructions for its Polarx and Polarx FIT cryoablation balloon catheters following an unexpected number of esophageal injury reports during atrial fibrillation treatments, the FDA announced. The update comes after seven reported injuries and four deaths associated with the devices, prompting the FDA to classify the correction as a Class I recall, indicating the highest level of risk. Despite no direct product performance issues identified, factors such as higher cryoablation frequency and intensity in real-world cases were noted as contributors. The FDA advises practitioners to closely monitor catheter placement relative to the esophagus and follow updated protocols to prevent thermal injuries.

DIVE INSIGHT Summary: The Polarx system, approved by the FDA in August 2023 and available in Europe since 2020, serves as a competitor to Medtronic’s cryoablation technology for recurrent, symptomatic atrial fibrillation treatment. Boston Scientific noted seven injury cases among the approximately 69,000 procedures performed globally. In response, the company has updated product guidelines, emphasizing practices like accurate cryoballoon positioning, esophageal monitoring, and avoiding ablation directly over the esophagus. This safety correction follows closely on the heels of another recall involving Boston Scientific’s Accolade pacemakers, which were linked to two deaths due to unintended entry into a safety mode.