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BOLSTER Clinical Study

BOLSTER Clinical Study
2Pages

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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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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,...

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BOLSTER Clinical Study 2Pages

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BOLSTER Clinical Study
2Pages