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# Spectranetics Bridge Occlusion Balloon Cleared by FDA
- URL: https://www.fdaweb.com/spectranetics-bridge-occlusion-balloon-cleared-by-fda/
- Published: 2016-02-08T12:00:00.000Z
- Updated: 2026-09-15T02:34:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134698

> FDA has cleared a Spectranetics 510(k) for the Bridge Occlusion Balloon for temporary vessel occlusion in cardiac lead extraction procedures. The device is designed to reduce blood loss if a tear occurs, including in the superior vena cava (SVC). The company says an SVC tear occurs in less than one half of 1% of lead extraction procedures. When it happens, the Bridge is intended to provide “temporary occlusion prior to a critical surgical intervention by deploying in under two minutes, occluding the SVC tear and stemming 90% of blood loss for at least 30 minutes,” it says.