Dive Brief:
- 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 number of reports of esophageal injury, specifically atrio-esophageal fistula, after catheter ablation procedures for atrial fibrillation.
- There have been seven reported injuries and four reports of death associated with the recall. The FDA identified the product correction as a Class I event, the most serious type of recall.
Dive Insight:
Physicians use the devices to treat recurrent, symptomatic atrial fibrillation, a type of irregular heartbeat. Boston Scientific won FDA approval in August 2023, establishing the Polarx system as a challenger to cryoablation technology sold by Medtronic. Polarx has been available in Europe since 2020.
Boston Scientific has received seven injury reports from the approximately 69,000 Polarx cases performed worldwide, according to the Heart Rhythm Society (HRS). A review of the injury reports found no concerns related to product performance, but some operators reported a higher frequency and intensity of cryoablation applications than studied in clinical trials. The HRS said the difference “likely contributed to the outcomes.”
The FDA said the affected devices may cause air bubbles to block blood vessels in the brain, bleeding in the stomach and intestines, septic shock and death. In response, Boston Scientific has updated its product instructions.
The company provided information on how to minimize potential esophageal injury, which was outlined in the FDA’s recall notice. Physicians should monitor the cryoballoon location relative to the esophagus prior to delivering cryotherapy and avoid performing cryoablation directly over the esophagus.
Boston Scientific also provided advice on how to minimize the potential for unintended thermal injury, including using standard-of-care practices for verifying balloon position, esophageal monitoring and phrenic nerve monitoring.
The FDA shared details of the correction days after publishing information on another Boston Scientific recall. The earlier recall covered Accolade pacemakers that can permanently enter safety mode, limiting functionality and the ability to treat some patients. The Accolade recall has been tied to two deaths.
