Bridge Occlusion Balloon
Kategori ID: 10
Açıklama: A tear in the Superior Vena Cava (SVC) during a lead extraction procedure is rare, occurring in just 0.05% of cases. But when a tear does occur, the Bridge Occlusion Balloon can be quickly deployed to stem blood loss and allow time for transition to surgical repair.
A bridge to control
The Bridge occlusion balloon can be deployed in less than two minutes via a pre-placed guidewire.² Bridge is easy to use, with no additional balloon preparation required. Radiopaque markers guide proper placement. Bridge is designed to cover the entire length and diameter of the SVC in 90% of patients.³
A bridge to safety
Once deployed, the Bridge occlusion balloon can dramatically reduce blood loss by up to 90% on average in tears up to 3.5 cm.⁴ With proper Bridge utilization, SVC tear survival in patients has gone from 56.4% to 91.7%.¹
A bridge to stability
Bridge occlusion balloon can provide at least 30 minutes of acceptable hemostasis⁵ - time to stabilize your patient and transition to surgery. With Bridge, the surgical team can approach the repair in a controlled setting with a clear field of view.
Specifications
| Catheter length | 90 cm |
| Balloon diameter: (nominal) | 20 mm |
| Balloon length: (nominal) | 80 mm |
| Maximum OD: (crossing profile) | 4mm / 0.157" |
| Minimum tip ID | 0.9mm / 0.035” |
| Maximum inflation volume | 60 cc |
Model Number 590-001
- 1. 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.
- 2. Document on file D027562. Bridge can be fully deployed in under one minute (53 seconds) in an animal model when pre-positioned on a guidewire, or in under two minutes (1 minute, 46 seconds) when not pre-positioned.
- 3. Document on file D027563. The balloon will cover the length and diameter of the SVC in 90% of the population as determined by analysis of 52 patients (N=52, % Male=48.1, Average Age 47.1 ± 16.5, Age Range 63 (18 to 81 years), Average Height 170.8cm ± 10.6, Height Range 40.6cm (152.4 to 193cm), Average BMI 29.8 ± 7.2, BMI Range 32.1 (18.2 to 50.3)).
- 4. Document on file D027561. When deployed, the Bridge occlusion balloon reduces blood loss by up to 90%, on average, in an animal model of an SVC tear. Testing was conducted in a heparinzed porcine model which has shorter SVC length than is typical in humans. A balloon design scaled for use specifically in the porcine model was used in generating this data.
- 5. Document on file, D026197. In an animal model with SVC tears up to 3.5 cm, with 2 pacing leads and 1 ICD lead.