Finally, the Control
You Need to Deliver
Accurate Treatment

When you reach for a balloon expandable stent, you require accuracy. The LifeStream® Balloon Expandable Covered Stent was developed using Bard's vast experience in PTA and covered stents to create a device designed for the challenging anatomy of iliac arteries and engineered to facilitate accurate placement. With a design that facilitates ease of trackability, low sheath profile, stent-specific marker bands, and minimal foreshortening, the LifeStream® Covered Stent helps you deliver accurate performance.

Low Sheath Profile

LifeStream® Covered Stent offers sizes on a 6F platform, which is the lowest sheath profile among balloon expandable covered stents on the U.S. market with an iliac indication.1

6F platform for
balloon
expandable
covered stent

LIFESTREAM® on a 6 French platform

Broad Size Matrix

LIFESTREAM® crimped covered stent length by diameter matrix

Ease of Delivery

The LifeStream® Covered Stent is designed to provide trackability to reach lesions through complex and tortuous anatomy - providing ease of delivery to the target lesion.

Non-Compliant Balloon Technology

Utilizing non-compliant balloon technology, the LifeStream® Covered Stent is designed to provide precise diameters and efface heavily-calcified iliac lesions.

Precise Diameters utilizing non-compliant balloon technology with average compliance of 1.1% at NP across all sizes

Designed for Trackability

LIFESTREAM® is designed for Trackability to reach lesions

Accurate Placement

The radiopaque marker bands of the LifeStream® Covered Stent have been specifically positioned on the balloon catheter at the ends of the crimped covered stent to facilitate accurate stent placement. And when millimeters count, the LifeStream® Covered Stent, with an average of 3.5% foreshortening across all balloon sizes at nominal inflation pressure4, achieved a high Acute Technical Success Rate of 98.3% in the BOLSTER Study.5

Stent-Specific Marker Bands

Maximum distance between inner border of marker band and covered stent end on each side = 0.80 mm

Minimal Foreshortening

(7 x 37 mm example)

Crimped 37.0 mm and at Nominal 8 ATM 35.6 mm (3.8%)

Optimized for Iliac Interventions

An optimized balloon design with short balloon shoulders and cones helps minimize dilatation of healthy tissue and reduce the risk of catheter entanglement during kissing stent procedures.

Line Drawing of Crimped LIFESTREAM® and relation of Radiopaque marker bands

BOLSTER Clinical Study

BallOon ExpandabLe Vascular Covered Stent in the Treatment of Iliac ArtERy Occlusive Disease

Study Design

Design
Prospective, Multi-Center, Non-Randomized, Single-Arm Study
Objective
Assess the safety and effectiveness of the LifeStream® Balloon Expandable Vascular Covered Stent for the treatment of stenoses and occlusions in the common and/or external iliac arteries
As-Treated Population
155 patients at 17 investigational sites (US, Europe, and New Zealand)
National Principal Investigator
John Laird, MD
Primary Endpoint
Composite safety and effectiveness measure defined as:
  • Device- and/or procedure-related death or MI through 30 days; or
  • Any TLR, major limb amputation, or restenosis (DUS) through 9 months
The primary endpoint is evaluated against a performance goal (PG) of 19.5%, which was derived from iliac stent published literature
Secondary Endpoints Included
  • Technical Success
  • Procedure Success
  • TLR/TVR
  • Primary Patency

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%.

Freedom from TLR6

96.1% Freedom From TLR at 300 Days

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

Indications
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.

Contraindications
Use in patients with uncorrected bleeding disorders. Patients who cannot receive recommended antiplatelet and/or anticoagulation therapy. Patients who are judged to have a lesion that prevents full expansion of the implant. Lesions in which the lumen diameter post balloon angioplasty is insufficient for the passage of the endovascular system. Lesion locations subject to external compression.

Warnings
Stenting across a vessel side branch may impede blood flow and hinder or prevent future procedures. Should excessive resistance be felt at any time during the insertion process, do not force passage. Do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter. Remove the sheath/guiding catheter and endovascular system as a single unit. Attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in stent dislodgement. Do not exceed the maximum rated burst pressure since this increases the potential for balloon rupture and vessel damage.

Precautions
Use caution when advancing the endovascular system through tortuous or difficult anatomy. This device has not been tested for use in overlapped conditions with stents or covered stents from other manufacturers.
Please consult package insert for more detailed safety information and instructions for use.

BD, the BD Logo, Bard, and LifeStream are trademarks of Becton, Dickinson and Company or its affiliates. © 2019 BD. All rights reserved. Illustrations by Mike Austin. Bard Peripheral Vascular, Inc. | www.bardpv.com | 1 800 321 4254 | 1625 W. 3rd Street Tempe, AZ 85281 BD-10789