Boston Scientific Updates Instructions for Cryoablation Balloons After Reports Of Severe Injuries

On Wednesday, Boston Scientific Corporation BSX revised the usage guidelines for 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 use instructions for POLARx Cryoablation Balloon Catheters due to a higher than anticipated number of reports of esophageal injury, specifically atrio-esophageal fistula, after catheter ablation procedures for atrial fibrillation.

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The updates emphasize the risk of atrio-esophageal fistula and practices that may minimize risk, based on the observation that location, frequency, and intensity of cryoablation applications may be contributing factors to this complication.

The use of affected product may cause serious adverse health consequences, including atrio-esophageal fistula leading to air bubbles blocking blood vessels in the brain (cerebral air embolism), stomach and intestinal (gastrointestinal) bleeding, a system-wide infection (septic shock), and death.

The devices, approved in the U.S. in August 2023, treat recurrent atrial fibrillation (an irregular heartbeat). Polarx has been in use in Europe since 2020.

Updated instructions now emphasize:

• Monitoring the catheter’s position relative to the esophagus.
• Avoiding cryotherapy directly over the esophagus.
• Using established practices for balloon positioning, esophageal monitoring, and nerve safety.

Earlier this week, Boston Scientific announced a recall for 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 being unable to properly regulate the heart’s rhythm and rate in some patients.

A device that enters Safety Mode should be replaced. The increased risk of permanently entering Safety Mode in this subset of Accolade pacemaker devices is due to the battery underpowering the system because of a manufacturing issue. 

Price Action: BSX stock is up 0.96% at $89.52 at last check Friday.

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