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Read all instructions thoroughly. Information in the IFU should be discussed with the patient, at the discretion
of the physician.
Please use the product illustration at the beginning of this booklet to guide you through the device description.
Device Description
The LifeStent™ XL Vascular Stent is designed to deliver a self-expanding stent to the peripheral vasculature via a sheathed delivery
system. LifeStent™ XL Vascular Stent is comprised of the following:
•
An implantable self-expanding nitinol (nickel-titanium alloy) stent (1), as shown in Figure 1 and Figure 2. The stent is
a flexible, fine tubular mesh prosthesis, with a helical design, which achieves its unconstrained diameter upon deployment
into the target vessel. Upon deployment, the stent imparts an outward radial force on the luminal surface of the vessel to establish
patency. (See Table 1 for more detailed information regarding materials or substances to which the patient may be exposed.)
Figure 2. LifeStent™ XL Vascular Stent
Material
Material or substance to which
the patient may be exposed
Nickel-Titanium (Nitinol)
per ASTM F2063
Titanium
Minor constituents
* approximately equal to the difference between 100% and the sum percentage of the other specified elements.
Table 1: Materials or substances to which the patient may be exposed
•
A delivery system, as shown in Figure 1, comprised of an inner tubing assembly that contains the guidewire lumen, a stent
delivery sheath (2) and a system stability sheath (3), which are linked together by means of a handle (4). The guidewire
lumen terminates distally in an atraumatic catheter tip (5) and originates proximally in a Luer hub (6) designed to accept
a compatible guidewire.
The self-expanding stent is constrained in the space between the guidewire lumen and stent delivery sheath. Unintended
stent movement during sheath retraction is restricted by the delivery system. The stent delivery sheath has a radiopaque zone (7)
at its distal end. The stent delivery system has a second radiopaque zone (9) proximal to the stent. Prior to deployment the
shipping lock (8) must be removed and discarded.
Refer to "Stent Deployment Procedure, Section 4. Deploy Stent" for directions on deploying the stent with the:
•
Thumbwheel (10)
•
Fast Track Deployment Lever (11)
The LifeStent™ XL Vascular Stent is intended:
- to widen or re-open constricted or occluded superficial femoral and popliteal arteries and to keep them open in order
to restore the blood flow;
- for use by physicians who have experience in vascular interventions;
- for adult patients with de-novo or restenotic lesions of the SFA or popliteal artery.
The LifeStent™ XL Vascular Stent is a permanent implant that is not intended to be removed after implantation.
Clinical benefits of the LifeStent™ XL Vascular Stent are:
- Minimally invasive treatment with low risk of procedural complications;
- Improvement of symptoms of peripheral arterial disease, improved ability to walk;
- Maintenance of arterial blood flow in lower limb and reduced risk of re-intervention compared to percutaneous
transluminal angioplasty (PTA).
For additional information on the product, refer to the Summary of Safety and Clinical Performance in the European database on medical
devices (Eudamed: https://ec.europa.eu/tools/eudamed) where it can be located using the Basic UDI-DI 038290WMKVGHRGMJ.
Indication for Use
The LifeStent™ XL Vascular Stent is indicated for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA)
and popliteal artery.
Contraindications
The LifeStent™ XL Vascular Stent is contraindicated for use in:
- Patients with a known hypersensitivity to nitinol (nickel, titanium).
Warnings
•
DO NOT use if the temperature exposure indicator (i.e., square label found on the pouch) is black as the unconstrained
stent diameter may have been compromised. The temperature exposure indicator label should be grey and must be
clearly visible on the pouch.
•
The LifeStent™ XL Vascular Stent is supplied STERILE (by ethylene oxide) 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 lead to injury, illness or death of the patient.
Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long
and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues
with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period
of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms
which may lead to infectious complications.
•
DO NOT use in patients with uncorrectable coagulation disorders.
DO NOT use in patients that cannot be adequately pre-medicated.
•
•
DO NOT use in patients with a target lesion with a large amount of adjacent acute or subacute thrombus.
•
DO NOT use in patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper
placement of the stent or stent delivery system.
•
DO NOT use the device if the sterile packaging has been damaged or unintentionally opened prior to use.
•
DO NOT use the device after the "Use By" date specified on the label.
•
Persons with allergic reactions to nitinol (nickel, titanium) may suffer an allergic response to this implant.
DO NOT expose the delivery system to organic solvents (e.g., alcohol).
•
•
The stent is not designed for repositioning or recapturing.
•
Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures.
•
If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol).
•
The safety and effectiveness of stent overlapping in the middle (P2) and distal popliteal artery (P3) has not yet been established.
•
The long-term outcomes following repeat dilatation of endothelialized stents are unknown.
Instructions for Use
wt. %
Material mass
Nickel
54.5 to 57.0
Balance*
each max. 0.050
Precautions
•
The delivery system is not designed for use with power injection systems.
•
Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.
•
Prior to stent deployment, remove slack from the delivery system catheter outside the patient.
•
If excessive force is felt during stent deployment, DO NOT force the delivery system. Remove the delivery system and replace
with a new unit.
•
DO NOT attempt to break, damage, or disrupt the stent after placement.
•
The safety and effectiveness of this device for use in treatment of in-stent restenosis has not been established.
•
Cases of fracture have been reported in clinical use of the LifeStent™ Vascular Stent. Cases of stent fracture occurred in lesions
that were moderate to severely calcified, proximal or distal to an area of stent overlap and in cases where stents experienced >10%
elongation at deployment. Therefore, care should be taken when deploying the stent as manipulation of the delivery system
may, in rare instances, lead to stent elongation and subsequent stent fracture. The long-term clinical implications of these
stent fractures have not yet been established.
•
One or more components of this device contain the following substance defined as CMR 1B in a concentration above 0.1%
weight by weight:
N-Methyl-2-pyrrolidinone (NMP; CAS 872-50-4)
N-Methyl-2-pyrrolidinone (NMP) is a solvent used in the manufacturing process of certain components of the LifeStent™
XL Delivery System. NMP has been shown to have adverse effects in experimental animals, including reproductive and
developmental effects. BD has not assessed any related adverse effects in relation to the exposure to NMP when this device
is used with neonates, infants, pregnant or breast-feeding women. It is the responsibility of the physician to assess risks
associated with the use of a device containing NMP.
Potential Complications and Adverse Events
Complications and Adverse Events which may occur include, but are not limited to the following:
(g)
•
Allergic reaction
•
Amputation
•
Arteriovenous fistula
•
Distal embolization
≤ 0.73
•
Hematoma
•
Hemorrhage
•
Ischemia complications
•
Infection
•
Open surgical intervention
•
Pseudoaneurysm
•
Renal impairment
Note: Users and/or patients should report any serious incident that has occurred in relation to the device to the manufacturer
and to either the European Union National Competent Authority or to the regulatory authority of the country in which the user
and/or patient is established.
Clinical Data
Study name/design: RESILIENT/randomized, prospective, multi-center study
Patient population: 206 patients with de-novo and restenotic (non-stented) lesion(s) in the SFA and/or proximal popliteal
artery were treated with the LifeStent NT or PTA alone
Key objectives: acute lesion success; target lesion revascularization (TLR)/ target vessel revascularization (TVR), primary
patency (PP)
Key results: acute lesion success 95.8% (LifeStent-arm) vs. 83.9% (PTA-arm) (p<0.01); freedom from TLR/TVR 87.3% (LifeStent-arm)
vs. 45.2% (PTA-arm) (12M; p<0.0001); PP 81.5% vs. 36.7% (12M; p<0.0001)
Study name/design: E-TAGIUSS/prospective, non-randomized, multi-center study
Patient population: 37 patients with lesions in the SFA or popliteal artery <200 mm and TASC A-C
Key objectives: safety through 30 days: freedom from death, stroke, myocardial infarction, emergent surgical revascularization,
significant distal embolization in target limb, amputation of the target limb and thrombosis of target vessel; effectiveness: successful
stent deployment at intended site with the post deployment stent length being within 10% of the pre-deployment stent length.
Key results: safety 97.3%, effectiveness 100%
Study name/design: Longer Lesion Study/retrospective non-randomized, multi-center analysis
Patient population: 293 patients with de-novo or restenotic segment lesions > 160 mm in the SFA or popliteal artery
Key objectives: estimated long-term safety (freedom from death and amputation), estimated freedom from target vessel
revascularization (TVR)
Key results: long-term safety 94.5% (12M), freedom from TVR 79.4% (lesion length up to 160 mm), 76.1% (lesion length up
to 200 mm) and 72.3% (lesion length up to 240 mm) (12M)
Study name/design: ETAP/randomized, controlled, multi-center study
Patient population: 246 patients with de novo obstructive lesions (stenosis, occlusion) of the popliteal artery were treated with
either the LifeStent™ (XL) Vascular Stent or PTA alone
Key objectives: restenosis, TLR, clinical endpoint (improvement in walking distance, ABI, clinical stage according to Rutherford
classification), stent fracture (SF)
Key results: restenosis 32.6% (LifeStent-arm) vs. 55.1% (PTA-arm) (p= 0.0021) at 12M; TLR 13% (LifeStent-arm) vs. 40%
(PTA-arm) at 12M and 13% (LifeStent-arm) vs. 48% (PTA-arm) at 24M, clinical endpoint similar between both groups; four SFs
(12M) and eight SFs (24M)
Study name/design: REALITY/single-arm, prospective, observational study
Patient population: 30 patients with lesions in the SFA and/or proximal popliteal artery and life-style limiting claudication
or minor tissue loss (Rutherford Category 2-5)
Key objectives: technical success (TS), freedom from TLR/TVR, primary patency (PP) and safety (freedom from death,
amputation, and TLR and/or TVR) for the additional 5 mm LifeStent™ and LifeStent™ XL Vascular Stent
Key results: TS 100%, freedom from TLR/TVR 100% (30d), PP 83% (12M), safety 100% (30d)
For more detailed clinical data refer to the Summary of Safety and Clinical Performance in the European database on medical
devices (Eudamed: https://ec.europa.eu/tools/eudamed) where it can be located using the Basic UDI-DI 038290WMKVGHRGMJ.
Magnetic Resonance Imaging (MRI) Safety Information
Non-clinical testing has demonstrated that the LifeStent™ XL Vascular Stent is MR Conditional. Patients with the LifeStent™ XL
Vascular Stent can be scanned safely, immediately after placement of this implant, under the following conditions:
•
Static magnetic field of 3-Tesla or less
•
Spatial gradient field of 720 Gauss/cm or less
•
Maximum specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning.
Note: Failure to follow these conditions may result in injury to the patient.
In non-clinical testing, the LifeStent™ XL Vascular Stent produced a temperature rise of less than or equal to 1.4 °C at a maximum
specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3-Tesla MR system (Excite, Software G3.052B, General
Electric Healthcare, Milwaukee, WI).
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the
LifeStent™ XL Vascular Stent. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.
Storage
Keep away from sunlight. Keep dry.
3
•
Restenosis
•
Surgical intervention
•
Stent fracture
•
Stent kinking / collapse
•
Stent migration
•
Stent misplacement
•
Thromboembolic event
•
Thrombosis
•
Vasospasm
•
Vessel occlusion
•
Vessel wall trauma
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