Bard Peripheral Vascular

The clinical study results demonstrated the safety and effectiveness of the LifeStream® Balloon Expandable Vascular Covered Stent for its intended use. As analyzed on a Pre-Specified basis, the primary composite endpoint result was 16.2% (p-value 0.1987). As analyzed on a Post-Hoc basis utilizing 12-month assessments and additional clinical factors... , the primary composite endpoint result was 11.6%. 1 As of April 2017. 2 5 mm - 8 mm diameters utilize a 37 mm base stent platform. 9 mm - 12 mm diameters utilize a 38 mm base stent platform. 3 Calculated as the percentage difference between the labeled balloon outer diameter and the actual balloon outer diameter at nominal pressure (NP). Across all balloon sizes, compliance ranged from 0% to 2.4%, with a mean of 1.1% at nominal pressure. Please consult package insert for the LifeStream® Covered Stent compliance chart. 4 Foreshortening is calculated as the difference, represented as a percentage, between the labeled covered stent length in crimped condition and the actual stent length measured at both nominal and at rated burst pressure. Across all balloon sizes, foreshortening ranged from -1.5% to 11.6% at nominal pressure, with a mean of 3.5%, and from -0.8% to 11.8% at rated burst pressure, with a mean of 4.6%. Please consult package insert for the LifeStream® Covered Stent foreshortening chart. 5 Acute Technical Success defined as successful deployment of the LifeStream® Covered Stent at the intended location, as determined by the investigator. BOLSTER Clinical Study. Data on file. Bard Peripheral Vascular, Inc., Tempe, AZ. 6 Based on Kaplan-Meier analysis of Freedom from TLR per subject (As Treated Population). BOLSTER Clinical Study. Data on File. Bard Peripheral Vascular, Inc., Tempe, AZ The LIFESTREAM® Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesion lengths up to 100 mm. Use in patients with ...Read More