Bridge occlusion balloon submitted for FDA 510(k) Premarket Notification for lead extraction procedures


The Bridge Occlusion Balloon from The Spectranetics Corporation has been submitted for US Food and Drug Administration (FDA) Premarket Notification 510(k). The device is designed to substantially reduce blood loss in the event of a superior vena cava tear (SVC) during a lead extraction procedure, providing a “bridge” to surgical intervention.

According to a press release, the device deploys in under one minute, conforming to the vessel, stemming blood flow and providing acceptable occlusion for at least 30 minutes. The device is designed to give the physician adequate time to safely transition the patient for surgical repair and to give the surgeon the benefit of a clear field of view for the repair procedure.

Jude Clancy, electrophysiologist, assistant professor of medicine and director, Lead Management Program at Yale Medical Group, New Haven, USA, says, “The device can add the critical element of time to minimally invasive lead removal protocols and help alleviate an extracting physician’s primary concern of gaining control during an SVC tear. The device provides physicians a sense of confidence so more indicated patients can have their leads removed safely.”

“Spectranetics is committed to safe, predictable and responsible lead management that saves lives and improves quality of life for patients. Our FDA submission advances our commitment to innovation and safety in cardiac lead removal,” says Donna Ford-Serbu, senior vice president of Sales and Marketing, Lead Management, Spectranetics. “Even though SVC tears during minimally invasive lead removal are rare, we aim for zero mortalities.”

The Bridge Occlusion Balloon has not been approved by the FDA for use in the United States.