Spectranetics Announces FDA Submission of Bridge(TM) Occlusion Balloon for Lead Extraction Procedures

COLORADO SPRINGS, Colo., The Spectranetics Corporation today announced U.S. Food and Drug Administration (FDA) Premarket Notification 510(k) submission of the Bridge Occlusion Balloon. Building on the long-standing clinical success and proven procedural safety of cardiac lead extraction, the Bridge Occlusion Balloon is designed to dramatically reduce blood loss in the rare event of a tear in the superior vena cava (SVC) during a lead extraction procedure, providing a "bridge" to surgical intervention.

The Bridge Occlusion Balloon deploys in less than 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.

"Upon a clearance to enter the U.S. market, the Bridge Occlusion Balloon will be the most significant innovation in lead management since the laser was introduced by Spectranetics 20 years ago," said Jude Clancy, MD, Electrophysiologist, Assistant Professor of Medicine and Director, Lead Management Program at Yale Medical Group, New Haven, Conn. "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," said Donna Ford-Serbu, Senior Vice President of Sales and Marketing, Lead Management, Spectranetics. "Even though SVC tears during minimally invasive lead removal are rare, occurring in less than 0.5% of procedures, we aim for zero mortalities."

Source: Spectranetics