Spectranetics, a Colorado Springs, CO firm, won FDA 510(k) clearance for its Bridge Occlusion Balloon, a device used to block large vessels, typically the superior vena cava (SVC), if a tear happens while removing cardiac leads. Though tears are rare, when they do happen the rapid blood loss can be difficult to manage.
The Bridge Occlusion Balloon can be deployed in under two minutes, preventing up to 90% of the blood from spilling out and clearing the damaged area for intervention. It can stay in place for up to 30 minutes while surgeons can focus on repairing the damage.
“The Bridge Occlusion Balloon represents the biggest breakthrough in lead management in the past 20 years,” in a statement said Jude Clancy, MD, Director of the Lead Management Program at Yale Medical Group, New Haven, Conn., and Lead Physician Investigator who will present clinical data on the Bridge Occlusion Balloon at HRS. “I believe Bridge will have a major impact on the field. It is imperative to have the right tools and techniques to support procedural safety. Bridge empowers extractors to take life-saving action while transitioning to surgical repair, driving positive patient outcomes.”