- Unique helical design engineered for bending, compression, torsion
- Only stent FDA-approved for the SFA and full popliteal artery1
- 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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- Overview
- EIFU & Resources
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Clinically Proven Stent Design:
As the only commercially available stent FDA-approved for the superficial femoral and full popliteal artery, the LifeStent™ Vascular Stent has a history of proven performance:
- In a Level 1 RESILIENT study, the LifeStent™ Vascular Stent demonstrated treatment superiority over balloon angioplasty with sustained effectiveness out to 3 years4
- In the investigator initiated, Level 1 ETAP study of the popliteal artery the LifeStent™ Vascular Stent demonstrated double the primary patency rate of PTA out to two years5
- In a clinical assessment of the treatment of long lesions, the LifeStent™ Vascular Stent demonstrated high primary patency at 12 months in lesions up to 240mm6
The LifeStent™ Vascular Stent Systems, in varying sizes, have been studied in more than ten clinical trials globally.7
Low Profile, 5F Delivery System:
The LifeStent™ 5F Vascular Stent System offers the same clinically-proven advanced helical stent design as the LifeStent™ Vascular Stent on a low profile, 5F delivery system. The LifeStent™ 5F delivery system offers dual speed thumbwheel deployment with a tri-axial catheter that is designed for ease of use, deployment control, and precise placement accuracy.2
The LifeStent™ 5F Vascular Stent System is part of the BD Halo Effect, suite of low profile products designed to minimize arteriotomy size and enable physicians to complete a 5F procedure when treating the SFA and popliteal artery. The BD Halo Effect also includes:
Increase Procedure Efficiency with GeoAlign™
The LifeStent™ 5F Vascular Stent System features the GeoAlign™ Marking System, which is a simple-to-use, non-radiopaque ruler on the catheter shaft. The GeoAlign™ Marking System is featured on all Bard 5F ProSeries™ products. The GeoAlign™ Marking System is designed to facilitate repeatable catheter alignment at the lesion and to increase procedure efficiency by minimizing fluoroscopy exposure.3
Peripheral stent intended to improve luminal diameter
The LifeStent™ 5F Vascular Stent System is a peripheral stent intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and popliteal artery. The LifeStent™ 5F Vascular Stent System is available in 5 mm, 6 mm, and 7 mm diameters; and 20 mm to 170 mm in length. Refer to the specifications table for specific size options.
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Please note, not all products, services or features of products and services may be available in your local area. Please check with your local BD representative.
- Commercially available as of December 2020
- Based on physician ratings during animal testing. May not be indicative of clinical performance. Data on file at Bard Peripheral Vascular, Inc., Tempe, AZ.
- 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.
- 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.
- 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.
- 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.
- 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 for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information.
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