Deep venous stents

Abre™ venous self-expanding stent system

<p>The Abre™ venous self-expanding stent system is designed for the unique challenges of venous disease.</p>

Indications, Safety, and WarningsIndications for useThe Abre™ venous self-expanding stent system is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.Cautions

This device was designed for single use only. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination, which could result in patient injury, illness, or death.

If unusually high resistance is encountered when advancing the Abre™ delivery system over the guidewire, assess the cause of the resistance before proceeding.

If high resistance is felt when initially rotating the thumbwheel, do not force deployment. Carefully withdraw the system and do not use it.

Do not use in patients with a total venous occlusion that cannot be dilated to allow passage of the guidewire.

Do not use the device with contralateral access.

Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures.

Contraindications

Do not use the Abre™ system with patients with known hypersensitivity to nickel titanium (nitinol).

Do not use the Abre™ system with patients who are judged to have a lesion that prevents complete inflation of a balloon dilatation catheter or proper placement of the stent or the stent delivery system.

Do not use the Abre™ system with patients in whom anticoagulant or antiplatelet therapy is contraindicated.

Potential complicationsThe potential adverse events (or complications) that may occur or require intervention with the use of this device include, but are not limited to, the following:

Access failure

Access site infection

Allergic reaction to contrast medium or procedure medications

Allergic reaction to nitinol or other device materials

Aneurysm

AV fistula

Bleeding

Bruising

Death

Device breakage

Device maldeployment

Edema

Embolization

Fever

Hematoma

Hypertension

Hypotension, nausea, or other vasovagal response

Infection

Myocardial infarction, arrhythmia, or other cardiovascular insufficiency

Open surgical repair

Pain

Pseudoaneurysm

Renal insufficiency or renal failure (new or worsening)

Respiratory distress or pulmonary embolism

Sepsis

Stent fracture

Stent malapposition

Stent malposition

Stent migration

Stroke, paradoxical embolism, transient ischemic attack, or intracerebral hemorrhage

Tissue necrosis

Venous occlusion, restenosis, or thrombosis, within or outside of stented segment

Vessel damage, including intimal injury, dissection, perforation, or rupture

MRI safety informationMRI ConditionalNonclinical testing demonstrated that the Abre™ stent in single and overlapped conditions is MR Conditional for stents up to 150 mm.A patient with this device can be scanned safely, immediately after stent placement, under the following conditions:

Static magnetic field of 1.5 Tesla or 3.0 Tesla

Maximum spatial gradient magnetic field of 4000 Gauss/cm or less (40 T/m)

Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)

MR image quality may be compromised if the area of interest is in the exact location or close to the position of the Abre™ stent.MRI-related temperature riseUnder the scan conditions as defined in the previous section, MR conditional, the Abre™ stent is expected to produce a maximum temperature rise less than or equal to 5.2 C after 15 minutes of continuous scanning (per pulse sequence). The effect of temperature rise in the MRI environment for stents with fractured struts is not known.It is recommended that patients register conditions under which the implant can be scanned safely with the MedicAlert Foundation (medicalert.org) or equivalent organization.Artifact informationIn nonclinical testing, the maximum artifact size as seen on the gradient echo pulse sequence at 3.0 Tesla extends approximately 5 mm, relative to the size and shape of the Abre™ stent. The lumen of the stent can be visualized using the T1-weighted spin echo pulse sequence and the T1-weighted gradient echo pulse sequence at 3.0 Tesla.UC202103705dEN

Explore the Abre™ venous stent system.

Simplicity for you.
Durability for them.

Watch the Abre™ stent mechanism of action.

Indications

The Abre™ stent system is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

Clinical evidence

Clinically meaningful impact on quality of life through 36 months — in even the most complex patients.

36-month primary patency^†,1:

81.6% overall
97.1% NIVL
76.5% aDVT
70.4% PTS

View full evidence

Product details

Simplicity for you^1,2

Hear it from the expert.

Durability for them^1,2

Hear it from the expert.

Easy deployment to let you focus on your patient^1,2

The Abre™ stent minimizes jumping and foreshortening, landing precisely where you need it.²

Rotating thumbwheel offers predictable placement and auditory feedback.²

The Abre™ delivery system is designed for simplicity and the rotating thumbwheel offers auditory feedback.

Isolation sheath
Hemostatic valve
Introducer sheath
Retractable sheath
Inner shaft

The Abre™ delivery system is designed for simplicity and the triaxial shaft design increases stability during deployment.

Demonstrated endurance to give your patients freedom of movement^1,2

The nitinol Abre™ stent maintains lumen integrity and flow in diverse patients and anatomies.¹ It ensures radial strength and crush resistance, without compromising flexibility.²

Unique technology:

Open-cell design with three offset connection points
Struts customized to each size

Consistent behavior across a broad range of diameters and lengths.²

A young woman stretches her legs on a grassy hill.

Bench evidence shows long-term durability.² Clinical evidence shows real-world dependability, even in challenging cases.¹

0% fracture rate in clinical trial with 44% of stents extending below inguinal ligament into the common femoral vein (CFV)^‡,1
0% migration rate in clinical trial¹

Frequently asked questions

Expand All

The Abre™ venous self-expanding stent system is indicated for use in the iliofemoral veins to treat symptomatic venous outflow obstruction. It features a nitinol open-cell design for strength, flexibility, and durability, with proven 50-year fracture resistance.^1–3

The 12-month primary patency rate was 88%, and 36-month primary patency rate is 81.6%.^†,1 Both were based on Kaplan-Meier analyses. The freedom from reintervention (TLR) rate at 36 months is 83.7%.^§,1

The Abre™ venous stent is made of nickel-titanium alloy (nitinol).

The Abre™ venous stent demonstrated 85% fracture-free durability at 50 years in bench testing, compared to 64% fracture-free at 1.4 years for non-venous stents. The stent was tested under simulated hip flexion conditions, with 15% of Abre™ stents experiencing fractures at 50 years, compared to 35% of non-venous stents at 1.4 years.³

Contraindications include hypersensitivity to nitinol, lesions preventing complete inflation of a balloon dilatation catheter or proper stent placement.

Ordering information

Item number guide

The Abre venous stent comes in a broad range of sizes and diameters.

Stent diameter (mm)	Stent length (mm)
Stent diameter (mm)	40	60	80	100	120	150
10	AB9U10040090	AB9U10060090	AB9U10080090	AB9U10100090	AB9U10120090	AB9U10150090
12	—	AB9U12060090	AB9U12080090	AB9U12100090	AB9U12120090	AB9U12150090
14	—	AB9U14060090	AB9U14080090	AB9U14100090	AB9U14120090	AB9U14150090
16	—	AB9U16060090	AB9U16080090	AB9U16100090	AB9U16120090	AB9U16150090
18	—	AB9U18060090	AB9U18080090	AB9U18100090	AB9U18120090	AB9U18150090
20	—	AB9U20060090	AB9U20080090	AB9U20100090	AB9U20120090	AB9U20150090

Abre™ venous self-expanding stent system

Explore the Abre™ venous stent system.

Indications

Clinical evidence