Uploaded May 2026 | Updated September 2026, 2 weeks ago
Step-by-step instructions for prophylactic staging of Bridge Plus and how to deploy in the event of an emergency. With proper Bridge Plus utilization, SVC tear survival has gone from 56.9% to 88.2% [1]*
SVC tears during transvenous lead extractions (TLEs) are very rare, occurring in less than 0.5% of procedures. [2] When they do occur, the Bridge Plus Occlusion Balloon stops up to 90% of blood loss [3] and maintains acceptable hemostasis for at least 30 minutes [4], giving you time to stabilize your patient and transition to surgery.
*When staging the Bridge Balloon versus when no Bridge balloon is used
1. Compliant endovascular balloon reduces the lethality of superior vena cava tears during transvenous lead extractions. Bruce L. Wilkoff, MD, FHRS, Roger G. Carrillo, MD, MBA, FHRS, Ryan Azarrafiy, BA, Darren C. Tsang, BS, Thomas A. Boyle, BS.
2.Roger G. Carrillo, MD; Darren C. Tsang, BS; Ryan Azarrafiy, BA; Thomas A. Boyle, BS. Multi-Year Evaluation of Compliant Endovascular Balloon in Treating Superior Vena Cava Tears During Transvenous Lead Extraction. EHRA late-breaking trial, March 19, 2018.
3. Document on File, D027561 Marketing claims blood loss report for Bridge project 1338 - When deployed, the Bridge Occlusion Balloon reduces blood loss of an SVC tear by 89.7% (α=0.10), on average, in an animal model.
4. Document on file, D026197 & animal study - NGX028-IS17 - All animals had biological metrics measured for up to 45 minutes during occlusion and 15 minutes post device deployment.
Step-by-step instructions for prophylactic staging of Bridge Plus and how to deploy in the event of an emergency. With proper Bridge Plus utilization, SVC tear survival has gone from 56.9% to 88.2% [1]*
SVC tears during transvenous lead extractions (TLEs) are very rare, occurring in less than 0.5% of procedures. [2] When they do occur, the Bridge Plus Occlusion Balloon stops up to 90% of blood loss [3] and maintains acceptable hemostasis for at least 30 minutes [4], giving you time to stabilize your patient and transition to surgery.
*When staging the Bridge Balloon versus when no Bridge balloon is used
1. Compliant endovascular balloon reduces the lethality of superior vena cava tears during transvenous lead extractions. Bruce L. Wilkoff, MD, FHRS, Roger G. Carrillo, MD, MBA, FHRS, Ryan Azarrafiy, BA, Darren C. Tsang, BS, Thomas A. Boyle, BS.
2.Roger G. Carrillo, MD; Darren C. Tsang, BS; Ryan Azarrafiy, BA; Thomas A. Boyle, BS. Multi-Year Evaluation of Compliant Endovascular Balloon in Treating Superior Vena Cava Tears During Transvenous Lead Extraction. EHRA late-breaking trial, March 19, 2018.
3. Document on File, D027561 Marketing claims blood loss report for Bridge project 1338 - When deployed, the Bridge Occlusion Balloon reduces blood loss of an SVC tear by 89.7% (α=0.10), on average, in an animal model.
4. Document on file, D026197 & animal study - NGX028-IS17 - All animals had biological metrics measured for up to 45 minutes during occlusion and 15 minutes post device deployment.
