- Unique helical design engineered for bending, compression, torsion
- The LifeStent™ 5F Vascular Stent System is indicated for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and popliteal artery.
- Low profile, 5F delivery system
- Dual-speed thumbwheel deployment designed for ease of use and placement accuracy2
- GeoAlign™ Marking System designed to increase procedural efficiency and reduce radiation exposure3
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LifeStent™
Vascular stents
LifeStent™ 5F Vascular Stent System
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LifeStent™ 5F Vascular Stent System
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- Overview
- Specifications
- eIFUs and Resources
- Product Notifications
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GTIN - Each
00801741120657
1
Catheter Diameter
5F
Catheter Length
135 cm
Guidewire Length
0.014" - 0.035"
Stent Diameter
5 mm
Stent Length
120 mm
GTIN
| GTIN - Each | 00801741120657 | 1 |
Product Basic Specification
| Catheter Diameter | 5F |
| Catheter Length | 135 cm |
| Guidewire Length | 0.014" - 0.035" |
| Stent Diameter | 5 mm |
| Stent Length | 120 mm |
Things to Consider
If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.
To better facilitate our investigation, please include the following information in your reporting:
- Product Name and/or Catalog Number
- Lot Number or Serial Number
- Any injuries and/or Harm?
- What is the issue you experienced?
- Is the actual sample or sample representative available? (If possible, please send affected sample)
- Contact name and phone number
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.
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