Marlborough, Massachusetts-based Boston Scientific’s notice relates to the PolarX and PolarX FIT cryoablation catheters. These systems work as part of the PolarX cryoablation system, used with the SmartFreeze console. The company updated the instructions for use (IFUs) because of an apparent risk of atrio-esophageal (AE) fistula.
AE fistula is a known and apparent risk for patients undergoing catheter ablation for AFib, the notice says. Although uncommon, esophageal injury can prove life-threatening due to the proximity of the esophagus to the posterior left atrium.
Since the commercial introduction of PolarX in 2020, Boston Scientific received seven reports of AE fistula following AFib ablations. Of those reports. four were associated with a patient death.
Boston Scientific said that detailed investigation did not identify product performance-related issues with any component of the cryoablation system. However, investigations found cryoablation intensity and frequency as potential contributing factors.
Because of this, the company updated the IFUs to emphasize the risk of AE fistula. Following applicable regulatory approval, the company plans to package and ship updated IFUs with corresponding PolarX systems.
“Patient safety remains Boston Scientific’s highest priority,” the company’s notice said. “We are committed to ensuring you have timely, relevant information for managing your patients and optimizing safe and effective product use.”
