Medtronic AB9U10060090 Instructions for Use

Abre™

Venous Self-expanding Stent System

Instructions for Use

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Abre™

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Manufacturer

Date of manufacture

Use-by date

Batch code

Catalog number

Sterilized using ethylene oxide

Do not reuse

Do not use if package is damaged

MR Conditional

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Keep away from sunlight

Keep dry

Compatible guidewire

Minimum sheath inner diameter

Lumen diameter

Consult instructions for use at this website

For US audiences only

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

1 Device description

The Abre venous self-expanding stent system (Abre system) is a vascular self-expanding nitinol stent system. The
Abre stent is intended for permanent implant and comes premounted on a 9 Fr delivery system inserted over a

0.89 mm (0.035 in) wire.

• The Abre self-expanding stent, as shown in Figure 1, is cut from a nickel titanium alloy (nitinol) tube in an open
lattice design (1), with integral nitinol markers at the trailing end (2) and the leading end (3) of the stent. Upon
deployment, the Abre stent exerts an outward force to establish patency.

• The Abre delivery system, as shown in Figure 1, has a triaxial shaft design, comprised of an inner shaft assembly
(4), a retractable sheath (silver, 5), an isolation sheath (blue, 6), and an ergonomic handle (7). The inner shaft
assembly terminates with a flexible catheter tip (9) and originates at the luer hub (10). The deployment handle (7)
has a removable locking pin (11), thumbwheel (12), and luer hub (10).

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• The radiopaque markers, at the trailing end and the leading end of the stent, guide stent positioning at the target
lesion before Abre stent deployment. There is a single luer hub on the deployment handle. A thumbwheel on the
deployment handle rotates to pull back the retractable sheath (silver). A locking pin prevents the stent from being
deployed before use and must be removed to actuate the thumbwheel. The Abre stent is fully deployed when the
radiopaque marker (8) in the retractable sheath (silver) reaches beyond the integral nitinol markers on the trailing
end of the stent. A uniquely designed isolation sheath (blue, attached to the deployment handle) improves control
and accuracy of stent delivery.

Figure 1. Abre venous self-expanding stent system

2 Intended purpose

The intended purpose of the Abre system is to restore lumen patency and blood flow.

2.1 Indications for Use

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

2.2 Intended users

The Abre stent system is intended for use by physicians who have experience with interventional techniques in the
vascular system.

2.3 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 dilation 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.

3 Warnings

• 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.

4 Precautions

• Federal law restricts this device to sale by or on the order of a physician.

• Use of the Abre stent in vessel beds other than the iliofemoral vein region has not been studied.

• Abre stent system implant procedures should only be performed by physicians that have experience with
interventional techniques in the vascular system.

• Avoid placing the cranial end or caudal end of the stent within the common iliac vein at the transition curve to the
external iliac vein and internal iliac confluence. Improper placement of the stent may result in tenting or kinking
of the vessel. Extending the stent length beyond the transition curve is recommended to minimize risk of
migration. Stent migration can potentially lead to vessel occlusion, thrombus formation, vessel damage,
embolism, and/or the need for surgical intervention, including open surgical removal from the heart.

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• Selection of the appropriate stent diameter and length is crucial. An undersized stent can result in stent migration
and suboptimal luminal diameter. Stents with a diameter of ≤14 mm and/or lengths of ≤80 mm should be
assessed for applicability as a stand-alone stent because of migration risk, particularly in non-thrombotic iliac
vein lesions and in patients that have had a previous DVT, but otherwise have normal veins with an iliac vein
compression.

• Ensure that there is appropriate stent apposition to the vessel wall to secure sustained fixation through changing
vessel size and shape during the procedure and post-procedural patient movement. Options to ensure
appropriate stent apposition include visualization with IVUS during the procedure, confirming that the stent is
extended around a curve, that the stent diameter is constrained by the vessel below the stent’s nominal diameter,
or that the stent is anchored by a second stent.

• Carefully inspect the sterile package and device before use to verify that no damage occurred during shipment.
Do not use the stent system if it is damaged or compromised.

• Carefully remove the system from the tray and tube without kinking the system. Do not use the system if it is
kinked.

• Do not use the stent system if the Abre stent is partially deployed before starting the procedure.

• Gain access at a distance far enough from the intended treatment site to ensure that the introducer sheath does
not intrude into the intended treatment site. Gaining access too close to the intended treatment site can lead to
difficulty with stent deployment.

• Always use an introducer sheath during the implant procedure to protect both the vessel and puncture site.

• Ensure that the locking pin remains in locked position until the target site is reached.

• If the retractable sheath (silver) is exposed beyond the hemostatic valve when the stent is positioned for
deployment, pull the introducer sheath back so that the hemostatic valve covers the end of the isolation sheath
(blue) and is not in direct contact with the retractable sheath. Friction from direct contact between the retractable
sheath and the hemostatic valve can cause difficult stent deployment or inaccurate stent placement.

• Do not reposition the Abre stent after establishing apposition against the vessel wall. Repositioning the stent may
cause stent elongation, stent fracture, or vessel damage.

• The Abre delivery system is not designed for recapturing the stent.

• The Abre stent is not designed to be lengthened or shortened from its nominal length. Excessive stent
lengthening or shortening can increase the risk of stent fracture.

• If resistance is felt when withdrawing the system, do not force withdrawal. Forcing withdrawal can cause catheter
separation and embolism.

• Use care when crossing a deployed Abre stent with any adjunct device to avoid stent dislodgement or damage
to the adjunct device.

• Dispose of the delivery system and accessories in accordance with applicable laws, regulations, and hospital
procedures, including those regarding biohazards, microbial hazards, and infectious substances.

5 Potential adverse events

The 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

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• 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

6 Summary of clinical studies

The clinical evidence supporting the safety and effectiveness of the Abre venous self-expanding stent system for
symptomatic iliofemoral venous outflow obstruction was derived from an Investigational Device Exemption (IDE)
study, the ABRE Study. A summary of the ABRE Study is presented below.

7 Primary clinical study

7.1 Study design

The ABRE Study was a prospective, multi-center, single-arm study. Safety and effectiveness were designed to be
evaluated against performance goals developed from the scientific literature. A total of 200 subjects were included
at 24 investigational sites in the United States and Europe. Subjects were categorized as acute Deep Vein
Thrombosis (DVT), Post-Thrombotic Syndrome (PTS), or Non-thrombotic Iliac Vein Lesion (NIVL).

Subjects in the ABRE Study were evaluated at a screening visit, during the index procedure, through hospital
discharge, and then at 30 days, 6 months, and 12 months. Additional follow-up evaluations are ongoing at 24 months
and 36 months post-procedure.

Subjects eligible for enrollment were males and non-pregnant females 18 to 80 years of age, with at least 1 clinical
indicator of lower extremity venous disease: Clinical-Etiological-Anatomical-Pathophysiological score (CEAP) ≥3,
Venous Clinical Severity Score pain score (VCSS) ≥2, and/or suspected DVT. All subjects had venographic and/or
Intravascular Ultrasound (IVUS) diagnosis of non-malignant venous obstruction (occlusion or ≥50% in diameter
reduction or ≥50% area reduction by IVUS) within the Common Iliac Vein (CIV), External Iliac Vein (EIV), and/or
Common Femoral Vein (CFV) per the Clinical Investigational Plan (CIP). Subjects with acute DVT within 14 days of
onset of associated symptoms were included in the study if the acute DVT was treated and venography confirmed
30% or less residual thrombus.

Subjects were not permitted to be enrolled in the study if they had peripheral arterial disease symptoms in the
target-limb or active vasculitic inflammatory disorder. Subjects were also excluded from the study if they had 1 or more
of the following: vena cava obstruction, lesions extending into the Inferior Vena Cava (IVC), bilateral iliofemoral
venous lesions requiring planned treatment within 12 months, or a previously placed stent in the ipsilateral venous
vasculature.

Endpoint-related safety events were adjudicated by an independent Clinical Events Committee (CEC). An
independent Data Safety Monitoring Board (DSMB) monitored participant safety and the continued validity and
scientific merit of the study.

7.2 Primary Endpoints

The primary effectiveness endpoint of the study was primary patency, evaluated at 12 months post-procedure.
Primary patency at 12 months was defined as meeting all of the following criteria: freedom from occlusion of the
stented segment of the target lesion, freedom from restenosis ≥50% of the stented segment of the target lesion, and
freedom from clinically driven TLR. Clinically driven was defined as the recurrence of symptoms present at baseline
or the onset of new symptoms including, but not limited to: venous pain, swelling, dermatitis, or ulceration related to
the target limb, as adjudicated by the CEC.

The primary safety endpoint of the study was the incidence of composite MAEs at 30 days post-procedure. The
components of the 30-day MAE composite included: all-cause death occurring post-procedure, clinically significant
(i.e. symptomatic, confirmed by Computed Tomography (CT) pulmonary angiography) pulmonary embolism, major
bleeding complication (procedural), stent thrombosis, and stent migration. Stent thrombosis was defined as
occlusion of the stented venous segment occurring at any time following stent placement. Stent migration was
defined as position change of a properly sized venous stent, with displacement of the stent outside of the intended
treatment segment after the index procedure. Stent migration was determined with regard to a reference anatomic
structure. All MAEs were adjudicated by a CEC, except for stent thrombosis and stent migration, which were
confirmed by core laboratory.

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