- The FDA issues 510(k) clearance for Spectranetics' (NASDAQ:SPNC -1.4%) Bridge Occlusion Balloon for temporary vessel occlusion in cardiac lead extraction procedures. The device is designed to significantly reduce blood loss in the rare event of a tear, including the superior vena cava (SVC), providing a bridge to surgical intervention.
- A tear in the SVC occurs in less than 1% of lead extraction procedures. If one does occur, the Bridge Occlusion Balloon and stop up to 90% of the blood loss for at least 30 minutes.