Wednesday, Boston Scientific Corporation (NYSE:BSX) has revised the guidelines for use of its Polarx and Polarx FIT cryoablation balloon catheters following reports of serious injuries, including seven cases of esophageal damage and four deaths.
Boston Scientific is updating the Instructions for Use for POLARx Cryoablation Balloon Catheters due to a higher than expected number of reports of esophageal injury, particularly atrioesophageal fistula, following esophageal procedures. catheter ablation for atrial fibrillation.
Also read: Why is medical device giant Boston Scientific's stock up on Monday?
The updates focus on the risk of atrioesophageal fistula and practices that can minimize this risk, based on the observation that the location, frequency and intensity of cryoablation applications could be contributing factors to this complication.
Use of the affected product may cause serious adverse health consequences, including atrioesophageal fistula resulting in air bubbles that block blood vessels in the brain (cerebral gas embolism), gastrointestinal bleeding, systemic infection (septic shock) and death.
The devices, approved in the United States in August 2023, treat recurrent atrial fibrillation (an irregular heartbeat). Polarx has been used in Europe since 2020.
The updated instructions now emphasize:
- Monitoring the position of the catheter in relation to the esophagus.
- Avoid cryotherapy directly on the esophagus.
- Use of established practices for balloon positioning, esophageal monitoring, and nerve safety.
Earlier this week, Boston Scientific announced the recall of a subset of Accolade pacemaker devices with an increased risk of permanently entering safety mode. This mode has limited functionality and has been associated with the pacemaker's inability to properly regulate heart rate and rhythm in some patients.
A device that enters safety mode must be replaced. The increased risk of permanently entering failsafe mode in this subset of Accolade pacemaker devices is due to the system battery being underpowered due to a manufacturing issue.
Price Movement BSX stock was up 0.96% to $89.52, as of last check on Friday.
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