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LifeStent™ Solo™ Vascular Stent System

FDA-approved for the SFA and full popliteal artery

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Overview

The LifeStent™ Solo™ Vascular Stent is the first commercially available 200 mm stent in the U.S. and potentially enables a single-stent solution. The LifeStent™ Solo™ Vascular Stent has sustained effectiveness up to three years in longer lesions. Furthermore, its enhanced delivery system is designed to reduce delivery system-dependent stent compression or elongation and enhance deployment accuracy. The LifeStent™ Vascular Stent Systems, in varying sizes, have been studied in more than ten clinical trials in the United States and globally.

The LifeStent™ Solo™ Vascular Stent is a peripheral stent intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 – 6.5mm. The LifeStent™ Vascular Stent is the only FDA-approved stent for the SFA and full popliteal artery. The LifeStent™ Solo™ Vascular Stent is available in 6 mm and 7 mm diameters and 200 mm in length.

Additionally, the LifeStent™ Vascular Stent is available in 5 mm, 6 mm, and 7 mm diameters; and 20 mm to 170 mm in length. To learn more about the LifeStent™ Vascular Stent, please click here

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Features and Benefits
Longest lesion length indication (up to 240 mm)1
Proven performance in long lesions2
Designed for enhanced distal and proximal stent placement accuracy
Treat longer lesions with one stent
Reference

As of December 2023

 

2  LifeStent™ Solo™ Vascular Stent Delivery System Study. A single-arm, prospective, non-randomized, multi-center study evaluating the safety and effectiveness of the LifeStent™ Solo™ in the treatment of symptomatic vascular disease of the SFA and/or proximal popliteal artery. Subjects were treated with conventional PTA followed by implantation of the LifeStent™ Vascular Stent. The LifeStent™ 5 mm diameter was not included in this 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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BD-23531v2

References

As of December 2023

 

2  LifeStent™ Solo™ Vascular Stent Delivery System Study. A single-arm, prospective, non-randomized, multi-center study evaluating the safety and effectiveness of the LifeStent™ Solo™ in the treatment of symptomatic vascular disease of the SFA and/or proximal popliteal artery. Subjects were treated with conventional PTA followed by implantation of the LifeStent™ Vascular Stent. The LifeStent™ 5 mm diameter was not included in this trial.

 

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

true

BD-23531

EIFUs
Resources
References

As of December 2023

 

2  LifeStent™ Solo™ Vascular Stent Delivery System Study. A single-arm, prospective, non-randomized, multi-center study evaluating the safety and effectiveness of the LifeStent™ Solo™ in the treatment of symptomatic vascular disease of the SFA and/or proximal popliteal artery. Subjects were treated with conventional PTA followed by implantation of the LifeStent™ Vascular Stent. The LifeStent™ 5 mm diameter was not included in this 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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BD-23531