LifeStent™ 5F Vascular Stent System

1. Commercially available as of December 2020

2. Based on physician ratings during animal testing. May not be indicative of clinical performance. Data on file at Bard Peripheral Vascular, Inc., Tempe, AZ.

3. The GeoAlign™ Marking System provides an approximation that may not be an exact representation of the distance traveled intravascularly and should be confirmed under fluoroscopy.

4. Freedom from TLR at 3 years: 75.5% LifeStent™ Vascular Stent arm (n=134), 41.8% PTA arm (n=72), p LifeStent™ Vascular Stent in 6 mm and 7 mm diameters and lengths of 40-80 mm. The LifeStent™ 5 mm stent diameter and LifeStent™ 5F delivery system were not included in these clinical studies.

5. Primary Patency at 2 years: 64.2% LifeStent™ Vascular Stent arm (n=89), 31.3% PTA arm (n=94), p=0.0001. Patency rates calculated when provisional stenting is considered TLR. Kaplan-Meier analysis with Mantel-Cox log-rank test. The study included LifeStent™ Vascular Stent in 6 mm, 7 mm and 8 mm diameters and lengths of 20-170 mm. The LifeStent™ 5 mm stent diameter and LifeStent™ 5F delivery system were not included in these clinical studies.

6. Primary Patency at 12 months: 81.5% all lesion lengths (n=53). This study included LifeStent™ Vascular Stent in 6 mm and 7 mm diameters and lengths of 20-200 mm. The LifeStent™ 5 mm stent diameter and LifeStent™ 5F delivery system were not included in these clinical studies.

7. RESILIENT I/II Trials, E-TAGIUSS Trial, STELLA Trial, Retrospective Analysis of LifeStent™ Vascular Stent Systems in the Treatment of Long-Segment Lesions, LifeStent™ Vascular Stent Delivery System Study (LifeStent™ 200 mm Trial), CONTINUUM Trial, REALITY I/II/III Trials, ETAP Trial, and RELIABLE Trial.

Please consult Instructions for Use under Resources for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information.