Spectranetics—Bridge Occlusion Balloons: Electrophysiologists May Not Be Aware of Potential for Thrombus Formation

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Spectranetics states that it became aware of an unpublished physician study that suggests potential formation of thrombus on above balloons when staged in patients for an extended period of time. The preliminary study results suggest that intravascular balloon staging with prolonged dwell times (average of 176 ±118 minutes) may be associated with an increased risk of thrombus formation. This study had one reported pulmonary embolism identified three days post procedure, which has not been attributed to the device. Spectranetics also states that the rate of occurrence of the risk of harm is deemed to be remote (0.0108%), as no additional complaints for thrombus formation have been reported over the lifetime of the device outside this preliminary study. This rate is within the expected range for lead extraction per HRS guidelines. Spectranetics further states that the safety of the Bridge occlusion balloon has been well-proven among thousands of lead extractions over the last several years and remains effective in occluding SVC tears, significantly reducing the probability of mortality when used properly. Because of the rapid rate of blood loss associated with SVC tears,...