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.
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Bridge is distributed by LifeSystems in Australia and New Zealand.
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