Spectranetics Corporation announced U.S. Food and Drug Administration (FDA) Premarket Notification 510(k) clearance of the Bridge Occlusion Balloon for temporary vessel occlusion in cardiac lead extraction procedures.
The Bridge Occlusion Balloon builds on the long-standing clinical success and proven procedural safety of cardiac lead extraction.
The device is designed to dramatically reduce blood loss in the rare event of a tear, including in the superior vena cava (SVC), providing a “bridge” to surgical intervention.
Clearance of the Bridge Occlusion Balloon initiates a controlled market release with full market launch at the Heart Rhythm Society’s 37th Annual Scientific Sessions (HRS) in San Francisco, May 4-7, 2016.
