Spectranetics get FDA 510(k) clearance for bridge™ Occlusion Balloon
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.
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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.
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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.