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BOLSTER Clinical Study

BOLSTER Clinical Study

BOLSTER Clinical Study

Product catalog summary
Introduction
The document presents the BOLSTER Clinical Study, which evaluates the LIFESTREAM® Balloon Expandable Vascular Covered Stent for treating iliac artery occlusive disease. The study is prospective, multi-center, non-randomized, and single-arm, involving 155 patients across the US, Europe, and New Zealand.

Study Objective
The primary objective is to assess the safety and effectiveness of the LIFESTREAM® Stent in treating stenoses and occlusions in the common and/or external iliac arteries.

Primary Endpoint
The primary endpoint is a composite measure of safety and effectiveness, including device- or procedure-related death or myocardial infarction (MI) through 30 days, and any target lesion revascularization (TLR), major limb amputation, or restenosis through 9 months. The performance goal is set at 19.5%, with the study achieving 16.2% on a pre-specified basis and 11.6% on a post-hoc basis.

Secondary Endpoints
Secondary endpoints include technical success, procedure success, TLR/TVR, and primary patency.

Product Specifications
The LIFESTREAM® Stent is available in various sizes with catheter lengths of 80 cm and 135 cm. It is designed for trackability and ease of delivery, featuring a low sheath profile and minimal foreshortening.

Indications and Contraindications
The stent is indicated for treating atherosclerotic lesions in iliac arteries with diameters between 4.5 mm and 12.0 mm and lesion lengths up to 100 mm. Contraindications include use in patients with uncorrected bleeding disorders or those unable to receive antiplatelet therapy.

Warnings and Precautions
Warnings include potential impediment of blood flow when stenting across vessel side branches and risks associated with excessive resistance during insertion. Precautions advise caution in tortuous anatomy and note that the device has not been tested with stents from other manufacturers.

Conclusion
The LIFESTREAM® Covered Stent is engineered for accurate placement and ease of delivery, optimized for iliac interventions with features like stent-specific marker bands and non-compliant balloon technology.
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Catalog excerpts

BOLSTER Clinical Study-1

datapoints BOLSTER Clinical Study LifeStreamBalloon Expandable Vascular Covered Stent Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease Study Design The clinical study results demonstrate the safety and effectiveness of the LifeStream® Balloon Expandable Vascular Covered Stent for its intended use. As analyzed on a PreSpecified 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 TLR* Accurate LifeStream"Balloon Expandable Vascular Covered Stent Jr -Q -Q O Q_ ~cd > '> CO REPRESENTATIVE NAME 96.1% FREEDOM FROM Tl D at 300 I Lrdays PHYSICIAN’S SIGNATURE Time to Event (Days) * 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. LifeStream® Balloon Expandable Vascular Covered Stent 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. All Rights Reserved. Bard Peripheral Vascular, inc. | www.bardpv.com | 1 800 321 4254 | 1625 W. 3rd Street Tempe, AZ 85281 BPV/SGF1 /0317/0041 (2)

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BOLSTER Clinical Study-2

Accurate Placement Low Sheath Profile When you reach for a balloon expandable stent, you require accuracy. The LIFESTREAM® Balloon Expandable Covered Stent was developed using 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 Broad size matrix LIFESTREAM® Crimped Covered Stent Length (mm) 16 facilitate accurate placement. With a design anatomy of iliac arteries and engineered to 6F platform for balloon expandable covered stent that facilitates ease of trackability, low...

 Open the catalog to page 2

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