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Indication for Use

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

The LifeStream™ Balloon Expandable Vascular Covered Stent is contraindicated for 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

The LifeStream™ Balloon Expandable Vascular Covered Stent is supplied sterile and is intended for single use only. Do not resterilize and/or reuse the device. Reuse, resterilization, reprocessing and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or injury, illness or death of the patient. Patients with allergies or hypersensitivity to stainless steel or ePTFE may suffer an allergic response to this implant. Do not use if packaging/pouch is damaged. Use the device prior to the USE BY date specified on the package. Stenting across a vessel side branch may impede blood flow and hinder or prevent future procedures. Stenting into a bifurcation may compromise future diagnostic or therapeutic procedures. Should excessive resistance be felt at any time during the insertion process, do not force passage. Attempts to retract the covered stent into the sheath/guiding catheter may result in dislodgement and embolization of the covered stent. Maintain guidewire placement across the lesion and withdraw the endovascular system only until the proximal end of the covered stent is aligned with the tip of the sheath/guiding catheter. 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. The use of a pressure monitoring device is recommended to prevent over pressurization. Use only diluted contrast medium for balloon inflation. Do not use air or any gaseous medium to inflate the balloon as this may cause uneven expansion and difficulty in deployment of the covered stent. For the contrast/saline solution, a ratio of 50/50 is recommended. The covered stent cannot be repositioned after it is deployed. Do not retract the balloon until the balloon is fully deflated under vacuum. Confirm optimal covered stent wall apposition using standard angiographic techniques. If the covered stent has not achieved full wall apposition, a post dilation with an appropriately sized balloon should be performed. 5-8 mm devices may be post-dilated with balloons up to 10 mm in diameter. 9-12 mm devices may be post-dilated with balloons up to 12 mm in diameter. Do not expose the covered stent to temperatures higher than 500 °F (260 °C). ePTFE decomposes at elevated temperatures, producing highly toxic decomposition products. Use of a laser on or around the surface of the covered stent may result in damage to the covered stent and could create toxic fumes, which may harm the patient or operator. After use, the delivery system is a potential biohazard. Handle and dispose of it in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

Precautions

The device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions. Anatomical variances may complicate the procedure; use caution when advancing the endovascular system through tortuous or difficult anatomy. Prior to device use, refer to the Covered Stent Sizing Table on the label and read the Instructions for Use. Do not use if the delivery system cannot be properly flushed. Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage. This device has not been tested for use in overlapped conditions with stents or covered stents from other manufacturers. Store in a cool and dry place. Keep away from sunlight.

Potential Adverse Events

Potential patient / device adverse effects that may occur include, but are not limited to, the following: Abscess; allergic / anaphylactoid reaction; amputation; aneurysm / pseudoaneurysm; angina / coronary ischemia; arterial occlusion / thrombus, near the puncture site; arterial occlusion / thrombus, remote from puncture site; arterial occlusion / restenosis of the treated vessel; arteriovenous fistula; arrhythmia; balloon rupture; blockage of major collateral artery or arterial branch; bypass surgery; covered stent dislodgement from balloon during tracking procedure; covered stent misplacement during placement procedure; covered stent migration post placement procedure; covered stent insufficient wall apposition; covered stent deformation / kink / fracture; death; distal embolization; drug reaction or allergic reaction to medication, substances or materials used for the procedure (e.g. anticoagulation or antiplatelet agent, contrast medium, stent or catheter materials); edema; fever; hemorrhage / bleeding; hematoma and / or bleeding at puncture (access) site; hypotension / hypertension; inability to introduce/withdraw endovascular system; inability to track endovascular system to the target lesion; inability to inflate the balloon / deploy covered stent; infection at access site; infection at or around implant; inflammation; ischemia / infarction of tissue/organ; malposition / malapposition; myocardial infarction; pain, radiation injuries; renal insufficiency / failure/ toxicity; respiratory arrest; restenosis in the treatment area / covered stent edge; sepsis; shock; stroke/ Transient Ischemic Attack (TIA); thromboembolic event / thrombosis; vasospasm, vessel wall trauma, perforation / dissection / rupture.

Please consult product labels and package inserts for indications, contraindications, hazards, warnings, precautions, and information for use.

BD-181691

LifeStream™ Balloon Expandable Vascular Covered Stent

^{Optimized for Iliac Interventions}

Overview
Overview
Clinical Experience
Products & Accessories
EIFU & Resources

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.

Performance is what we deliver

Novel stainless steel base stent fully encapsulated with two layers of ePTFE
Proven microporous ePTFE designed to resist neointimal growth
Implant conformability to the vessel anatomy¹

Images courtesy of Dr. Norby.

Individual results may vary

We've Got You Covered

The LifeStream™ Balloon Expandable Vascular Covered Stent was developed using BD'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.

Low Sheath Profile

Accurate Placement

Minimal Foreshortening

Ease of Delivery

Low Sheath Profile and Broad Size Matrix

LifeStream™ offers a broad size matrix on a low-profile 6F delivery platform for iliac interventions.

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 pressure², achieved a high Acute Technical Success Rate of 98.3% in the BOLSTER Study³.

Minimal Foreshortening

The LifeStream™ Balloon Expandable Vascular Covered Stent is designed to maximize your lesion coverage with minimal foreshortening and facilitate accurate placement.

Foreshortening Comparison

_{* The tables above show the calculated foreshortening based upon the respective product’s IFUs and labeling information. Foreshortening is calculated as the difference between the labeled covered stent length in crimped condition and the actual stent length measured at both nominal and at rated burst pressure. Results shown in simulated testing. Data on file, Bard Peripheral Vascular, Inc. Tempe, AZ.

Bench tests may not be indicative of clinical performance. Different test methods may yield different results. Please consult package insert for detailed safety information and instructions for use.

** Comparable sizes include (mm diameter x mm length): 5 x 16, 5 x 26, 5 x 37, 6 x 16, 6 x 26, 6 x 37, 6 x 58, 7 x 16, 7 x 26, 7 x 37, 7 x 58, 8 x 26, 8 x 37, 8 x 58, 9 x 38, 9 x 58, 10 x 38, 10 x 58.}

Ease of delivery with Trackability

The LifeStream™ Balloon Expandable Vascular Covered Stent is designed to provide trackability for ease of delivery through complex and tortuous anatomy

_{Results shown in simulated testing. Data on file, Bard Peripheral Vascular, Inc. Tempe, AZ. Bench tests may not be indicative of clinical performance. Different test methods may yield different results. Please consult package insert for detailed safety information and instructions for use.}

Download our Brochures

LifeStream™ Balloon Expandable Vascular Covered Stent Brochure

English

LifeStream™ Competitive Brochure

English

Safety & Warnings

¹5 mm - 8 mm diameters utilize a 37 mm base stent platform. 9 mm - 12 mm diameters utilize a 38 mm base stent platform.

² 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.

³ 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.

BD-82096v3

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.

Performance is what we deliver

Novel stainless steel base stent fully encapsulated with two layers of ePTFE
Proven microporous ePTFE designed to resist neointimal growth
Implant conformability to the vessel anatomy*

_{* Ability to post-dilate beyond nominal diameter with help conform to varying patient vessel diameters. 5-8 mm devices can be post-dilated with balloons up to 10 mm in diameter and 9-12 mm devices can be post-dilated with balloons up to 12 mm in diameter.}

Images courtesy of Dr. Norby.

Individual results may vary

We've Got You Covered

Low Sheath Profile

Accurate Placement

Minimal Foreshortening

Ease of Delivery

Low Sheath Profile and Broad Size Matrix

LifeStream™ Balloon Expandable Vascular Covered Stent pairs low-profile delivery options with a comprehensive size matrix, enabling treatment flexibility across a broad range of iliac artery inerventions.

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 achieved a high Acute Technical Success Rate of 98.3% in the BOLSTER Study.²

Minimal Foreshortening

Minimal foreshortening during expansion*
Designed for trackability through aorto-iliac crossover procedures with compatible guidewires
Triple lumen balloon shafts designed for fast deflation on large diameters**

_{* Foreshortening is calculated as the difference 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 LifeStream™ Covered Stent 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%. Results shown in simulated testing. Data on file. BD, Tempe, AZ. Bench tests may not be indicative of clinical performance. Different test methods may yield different results.}

_{** Balloon deflation time was defined as the required time to remove 50/50 contrast media from the balloon following inflation to rate burst pressure. The LifeStream™ Covered Stent had an average deflation time of 23.7 seconds across all sizes. Results shown in simulated testing. Data on file. BD, Tempe, AZ. Bench tests may not be indicative of clinical performance. Different test methods may yield different results}

Ease of delivery with Trackability

The LifeStream™ Balloon Expandable Vascular Covered Stent is designed to provide trackability for ease of delivery through complex and tortuous anatomy

_{Results shown in simulated testing. Data on file. BD, Tempe, AZ. Bench tests may not be indicative of clinical performance. Different test methods may yield different results. Please consult package insert for detailed safety information and instructions for use.}

LifeStream™ Covered Stent Brochure

English

LifeStream™ Covered Stent Comparative Brochure

English

¹5 mm - 8 mm diameters utilize a 37 mm base stent platform. 9 mm - 12 mm diameters utilize a 38 mm base stent platform.

² BOLSTER was a prospective, multicenter, single-arm study of 155 patients evaluating the LifeStream™ Covered Stent for iliac artery occlusive disease. The primary endpoint was defined as a composite of device- or procedure-related death or myocardial infarction through 30 days, or target lesion revascularization, major amputation of the target limb or restenosis through 9 months. The primary endpoint result was 16.2%. Secondary endpoints included acute technical success, defined as successful deployment of the LifeStream™ Covered Stent at the intended location as determined by the investigator. Laird JR, et al. J Vasc Interv Radiol. 2019;30(6):836-844.e1.

BD-82096v3

Explore Clinical Studies

BOLSTER
Belstream

Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease

Objective

Assess the safety and effectiveness of the LifeStream™ Balloon Expandable Vascular Covered Stent for the treatment of stenoses and occlusions in common and/or external iliac arteries.

Methods

The study was a prospective, multi-center, non-randomized, single-arm study. It enrolled 155 patients at 17 investigational sites (US, Europe, and New Zealand).

Outcomes

The primary endpoint of the study is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure. The endpoint was evaluated against a prespecified performance goal of 19.5%, which was derived from published iliac stent literature.

As analyzed on a Pre-Specified basis, the primary composite endpoint result was 16.2% (p-value 0.1987) and did not meet the pre-defined statistical performance goal. As analyzed on a Post-Hoc basis utilizing 12-month assessments and additional clinical factors, the primary composite endpoint result was 11.6%.

Reference

* BOLSTER was a prospective, multicenter, single-arm study of 155 patients evaluating the LifeStream™ Covered Stent for iliac artery occlusive disease.The primary endpoint was defined as a composite of device- or procedure-related death or myocardial infarction through 30 days, or target lesion revascularization, major amputation of the target limb or restenosis through 9 months. The primary endpoint result was 16.2%. Secondary endpoints included acute technical success, defined as successful deployment of the LifeStream™ Covered Stent at the intended location as determined by the investigator. Laird JR, et al. J Vasc Interv Radiol. 2019;30(6):836-844.e1.

BD-82096v3

A Belgian physician-initiated trial investigating the LifeStream peripheral stent graft system for the treatment of complex TASC C and D iliac lesions

Objective

To evaluate the safety and efficacy of the LifeStream™ Balloon Expandable Vascular Covered Stent for the treatment of complex TASC C and D aorto-iliac lesions.

Methods

The study was prospective, multi-center, non-randomized, single-arm and physician-initiated. It enrolled 70 patients with 133 complex TASC C and D aorto-iliac stenotic or occlusive lesions across 6 Belgian centers. Patients received LifeStream™ Vascular Covered Stents and were monitored for up to 60 months for patency and safety outcomes.

Conclusions

BELSTREAM demonstrated 100% freedom from periprocedural serious adverse events at 30 days, with no device‑ or procedure‑related deaths, major amputations, or early clinically driven reinterventions.

12 Month Results

Overall Cohort

Kissing Stent configuration

The study faced several limitations: imaging deep abdominal arteries with duplex ultra- sound was difficult and there was no core lab for independent review. It was prospective but lacked a concurrent control group, such as bare-metal or alternative covered stents. Enrollment was relatively small (70 patients), though 133 lesions were analyzed due to disease complexity.

Reference

¹Primary Patency was defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio greater than 2.5) and with freedom from TLR at 12 months.

²Target Lesion Revascularization (TLR) was defined as a repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.

* Deloose K, Gielis J, Maene L, et al . A Belgian physician-initiated trial investigating the LifeStream peripheral stent graft system for the treatment of complex TASC C and D iliac lesions. Journal of Cardiovascular Surgery(Torino). 2025;66(1):37-45. i:10.23736/S0021- 9509.24.13138-2.

BD-82096v3

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LifeStream™ Balloon Expandable Vascular Covered Stent

12 mm by 58 mm covered stent with 135 cm catheter

SKU/REF lsmu1351258
LifeStream™ Balloon Expandable Vascular Covered Stent

12 mm by 38 mm covered stent with 135 cm catheter

SKU/REF lsmu1351238
LifeStream™ Balloon Expandable Vascular Covered Stent

10 mm by 58 mm covered stent with 135 cm catheter

SKU/REF lsmu1351058
LifeStream™ Balloon Expandable Vascular Covered Stent

10 mm by 38 mm covered stent with 135 cm catheter

SKU/REF lsmu1351038
LifeStream™ Balloon Expandable Vascular Covered Stent

9 mm by 58 mm covered stent with 135 cm catheter

SKU/REF lsmu1350958
LifeStream™ Balloon Expandable Vascular Covered Stent

9 mm by 38 mm covered stent with 135 cm catheter

SKU/REF lsmu1350938
LifeStream™ Balloon Expandable Vascular Covered Stent

8 mm by 58 mm covered stent with 135 cm catheter

SKU/REF lsmu1350858
LifeStream™ Balloon Expandable Vascular Covered Stent

8 mm by 37 mm covered stent with 135 cm catheter

SKU/REF lsmu1350837
LifeStream™ Balloon Expandable Vascular Covered Stent

8 mm by 26 mm covered stent with 135 cm catheter

SKU/REF lsmu1350826
LifeStream™ Balloon Expandable Vascular Covered Stent

8 mm by 16 mm covered stent with 135 cm catheter

SKU/REF lsmu1350816
LifeStream™ Balloon Expandable Vascular Covered Stent

7 mm by 58 mm covered stent with 135 cm catheter

SKU/REF lsmu1350758
LifeStream™ Balloon Expandable Vascular Covered Stent

7 mm by 37 mm covered stent with 135 cm catheter

SKU/REF lsmu1350737
LifeStream™ Balloon Expandable Vascular Covered Stent

7 mm by 26 mm covered stent with 135 cm catheter

SKU/REF lsmu1350726
LifeStream™ Balloon Expandable Vascular Covered Stent

7 mm by 16 mm covered stent with 135 cm catheter

SKU/REF lsmu1350716
LifeStream™ Balloon Expandable Vascular Covered Stent

6 mm by 58 mm covered stent with 135 cm catheter

SKU/REF lsmu1350658
LifeStream™ Balloon Expandable Vascular Covered Stent

6 mm by 37 mm covered stent with 135 cm catheter

SKU/REF lsmu1350637
LifeStream™ Balloon Expandable Vascular Covered Stent

6 mm by 26 mm covered stent with 135 cm catheter

SKU/REF lsmu1350626
LifeStream™ Balloon Expandable Vascular Covered Stent

6 mm by 16 mm covered stent with 135 cm catheter

SKU/REF lsmu1350616
LifeStream™ Balloon Expandable Vascular Covered Stent

5 mm by 37 mm covered stent with 135 cm catheter

SKU/REF lsmu1350537
LifeStream™ Balloon Expandable Vascular Covered Stent

5 mm by 26 mm covered stent with 135 cm catheter

SKU/REF lsmu1350526
LifeStream™ Balloon Expandable Vascular Covered Stent

12 mm by 58 mm covered stent with 80 cm catheter

SKU/REF lsmu0801258
LifeStream™ Balloon Expandable Vascular Covered Stent

12 mm by 38 mm covered stent with 80 cm catheter

SKU/REF lsmu0801238
LifeStream™ Balloon Expandable Vascular Covered Stent

10 mm by 58 mm covered stent with 80 cm catheter

SKU/REF lsmu0801058
LifeStream™ Balloon Expandable Vascular Covered Stent

10 mm by 38 mm covered stent with 80 cm catheter

SKU/REF lsmu0801038
LifeStream™ Balloon Expandable Vascular Covered Stent

9 mm by 58 mm covered stent with 80 cm catheter

SKU/REF lsmu0800958
LifeStream™ Balloon Expandable Vascular Covered Stent

9 mm by 38 mm covered stent with 80 cm catheter

SKU/REF lsmu0800938
LifeStream™ Balloon Expandable Vascular Covered Stent

8 mm by 58 mm covered stent with 80 cm catheter

SKU/REF lsmu0800858
LifeStream™ Balloon Expandable Vascular Covered Stent

8 mm by 37 mm covered stent with 80 cm catheter

SKU/REF lsmu0800837
LifeStream™ Balloon Expandable Vascular Covered Stent

8 mm by 26 mm covered stent with 80 cm catheter

SKU/REF lsmu0800826
LifeStream™ Balloon Expandable Vascular Covered Stent

8 mm by 16 mm covered stent with 80 cm catheter

SKU/REF lsmu0800816
LifeStream™ Balloon Expandable Vascular Covered Stent

7 mm by 58 mm covered stent with 80 cm catheter

SKU/REF lsmu0800758
LifeStream™ Balloon Expandable Vascular Covered Stent

7 mm by 37 mm covered stent with 80 cm catheter

SKU/REF lsmu0800737
LifeStream™ Balloon Expandable Vascular Covered Stent

7 mm by 26 mm covered stent with 80 cm catheter

SKU/REF lsmu0800726
LifeStream™ Balloon Expandable Vascular Covered Stent

7 mm by 16 mm covered stent with 80 cm catheter

SKU/REF lsmu0800716
LifeStream™ Balloon Expandable Vascular Covered Stent

6 mm by 58 mm covered stent with 80 cm catheter

SKU/REF lsmu0800658
LifeStream™ Balloon Expandable Vascular Covered Stent

6 mm by 37 mm covered stent with 80 cm catheter

SKU/REF lsmu0800637
LifeStream™ Balloon Expandable Vascular Covered Stent

6 mm by 26 mm covered stent with 80 cm catheter

SKU/REF lsmu0800626
LifeStream™ Balloon Expandable Vascular Covered Stent

6 mm by 16 mm covered stent with 80 cm catheter

SKU/REF lsmu0800616
LifeStream™ Balloon Expandable Vascular Covered Stent

5 mm by 37 mm covered stent with 80 cm catheter

SKU/REF lsmu0800537
LifeStream™ Balloon Expandable Vascular Covered Stent

5 mm by 26 mm covered stent with 80 cm catheter

SKU/REF lsmu0800526

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Safety & Warnings

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