MULTI-LINK VISION Coronary Stent System (U.S.)

Features

MULTI-LINK VISION: Powered to Perform with Cobalt Chromium

Abbott Vascular is recognized as the world leader in stent design and innovation. This leadership continues with the ML VISION stent—an entirely new class of cobalt chromium stents.

The ML VISION stent is laser cut from cobalt chromium, which allows us to reduce strut thickness and total stent volume while maintaining excellent radial strength and radiopacity.

The result? Our most flexible stent yet, with the best clinical outcomes we've ever delivered.

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Cobalt Chromium: Powering a New Class of Stents

This superalloy is proven biocompatible. It's stronger and more radiopaque than stainless steel¹, allowing for thinner struts without sacrificing radial strength or radiopacity.

Superb Deliverability: Flexible, Low-Profile Design

The ML VISION stent offers superb flexibility and has the lowest profile available at just .040".² This combination provides confidence to succeed, even in challenging cases.

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37% Thinner Struts: More Thinking, Less Metal

The ML VISION stent has the thinnest struts³–just .0032"–leading to less vessel injury* and extraordinary outcomes.

Excellent Clinical Results: Clinically Driven TLR of 1.6%

The ML VISION stent proves its excellent performance with remarkable clinical data, including an impressive 6-month clinically driven TLR of 1.6%.^4,5

ASTM International. Data on file at Abbott Vascular.
Tests performed by and data on file at Abbott Vascular.
3.0 x 18 mm stent as compared to the most commonly used workhorse stents on the U.S. market, 2003. Tests performed by and data on file at Abbott Vascular.
Clinically driven TLR is defined in the VISION Registry as "Revascularization at the target site associated with any of the following: positive functional ischemia study, ischemic symptoms and an agiographic minimum lumen diameter stenosis ≥ 50% by QCA or revascularization of a target site with diameter stenosis ≥ 70% QCA without either angina or a positive functional study.
Kereiakes, et.al. AJCardio. 2003; 92:463-466

* As compared to ML Penta. Based on preclinical data on file at Abbott Vascular.

Specifications

MULTI-LINK VISION Part Numbers 31.7 KB

Indications and Important Safety Information

MULTI-LINK VISION Coronary Stent Systems

INDICATIONS

The MULTI-LINK VISION RX and MULTI-LINK VISION OTW Coronary Stent Systems are indicated for improving coronary luminal diameter in the following:

Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length ≤ 25 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm.
Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length ≤ 25 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm.
Restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by ST segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions of length ≤ 25 mm with a reference vessel diameter of 3.0 mm to 4.0 mm.
Outcome (beyond 9 months) for this permanent implant is unknown at present.

CONTRAINDICATIONS

The MULTI-LINK VISION RX and MULTI-LINK VISION OTW Coronary Stent Systems are contraindicated for use in:

Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated.
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.

WARNINGS AND PRECAUTIONS

WARNINGS

Judicious selection of patients is necessary since the use of this device carries the associated risk of subacute thrombosis, vascular complications and / or bleeding events.
Persons allergic to L-605 cobalt chromium alloy (including the major elements cobalt, chromium, tungsten, nickel) may suffer an allergic reaction to this implant.
Implantation of the stent should be performed only by physicians who have received appropriate training.
Stent placement should only be performed at hospitals where emergency coronary artery bypass graft surgery can be readily performed.
Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of endothelialized stents is unknown at present.
When multiple stents are required, stent materials should be of similar composition. Placing multiple stents of different metals in contact with each other may increase the potential for corrosion. The risk of in vivo corrosion does not appear to increase based on in vitro corrosion tests using an L-605 CoCr alloy stent (MULTI-LINK VISION Coronary Stent) in combination with a 316L stainless steel alloy stent (MULTI-LINK TETRA Coronary Stent).

Stent Handling – Precautions

For single use only. Do not resterilize or reuse. Note the product "Use By" date.
Do not remove stent from its delivery system as removal may damage the stent and / or lead to stent embolization. Stent system is intended to perform as a system.
Delivery system should not be used in conjunction with other stents.
Special care must be taken not to handle or in any way disrupt the stent on the balloon. This is most important during catheter removal from packaging, placement over guide wire and advancement through rotating hemostatic valve adapter and guiding catheter hub.
Do not manipulate (e.g., “roll") the stent with your fingers, as this action may loosen the stent from the delivery balloon.
Use only the appropriate balloon inflation media. Do not use air or any gaseous medium to inflate the balloon as this may cause uneven expansion and difficulty in deployment of the stent.

Stent Placement – Precautions

Do not prepare or pre-inflate delivery system prior to stent deployment other than as directed. Use balloon purging technique described in Delivery System Preparation .
Implanting a stent may lead to dissection of the vessel distal and / or proximal to the stent and may cause acute closure of the vessel requiring additional intervention (CABG, further dilatation, placement of additional stents, or other).
When treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the proximal lesion. Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the chances for dislodging the proximal stent.
Do not expand the stent if it is not properly positioned in the vessel. (See Stent / System Removal – Precautions)
Placement of a stent has the potential to compromise side branch patency.
Do not exceed Rated Burst Pressure (RBP) as indicated on product label. Balloon pressures should be monitored during inflation. Use of pressures higher than specified on product label may result in a ruptured balloon with possible intimal damage and dissection.
An unexpanded stent may be retracted into the guiding catheter one time only. Subsequent movement in and out through the distal end of the guiding catheter should not be performed as the stent may be damaged when retracting the undeployed stent back into the guiding catheter. Should any resistance be felt at any time during withdrawal of the coronary stent system, the entire system should be removed as a single unit.
Stent retrieval methods (use of additional wires, snares and / or forceps) may result in additional trauma to the coronary vasculature and / or the vascular access site. Complications may include bleeding, hematoma or pseudoaneurysm.

Stent / System Removal – Precautions

Should any resistance be felt at any time during either lesion access or removal of the delivery system post-stent implantation, the entire system should be removed as a single unit.

When removing the delivery system as a single unit: DO NOT retract the delivery system into the guiding catheter.
Position the proximal balloon marker just distal to the tip of the guiding catheter.
Advance the guide wire into the coronary anatomy as far distally as safely possible.
Tighten the rotating hemostatic valve to secure the delivery system to the guiding catheter; then remove the guiding catheter and delivery system as a single unit.

Failure to follow these steps and / or applying excessive force to the delivery system can potentially result in loss or damage to the stent and / or delivery system components.

If it is necessary to retain guide wire position for subsequent artery / lesion access, leave the guide wire in place and remove all other system components.

Post Implant – Precautions

Care must be exercised when crossing a newly deployed stent with a coronary guide wire, balloon or delivery system to avoid disrupting the stent geometr

MRI Statement

The MULTI-LINK VISION Coronary Stent has been shown in non-clinical testing to be MRI safe immediately following implantation. MRI test conditions used to evaluate this stent were: for magnetic field interactions, a static magnetic field strength of 3 tesla with a maximum spatial gradient magnetic field of 3.3 tesla/meter; for MRI-related heating, a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. While a single stent produced a temperature rise of less than 0.6°C and should not migrate under these conditions, the response of overlapping stents or stents with fractured struts is unknown. Non-clinical testing has not been performed to rule out the possibility of stent migration at field strengths higher than 3 tesla. 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 stent.

Potential Adverse Events

Adverse events may be associated with the use of a coronary stent in native coronary arteries:

Acute myocardial infarction
Arrhythmias, including VF and VT
Death
Dissection
Drug reactions to antiplatelet agents / contrast medium
Emboli, distal (air, tissue or thrombotic emboli)
Emergent coronary artery bypass surgery
Hemorrhage, requiring transfusion
Hypotension / hypertension
Infection and / or pain at insertion site
Ischemia, myocardial
Perforation
Pseudoaneurysm, femoral
Restenosis of stented segment
Spasm
Stent embolization
Stent thrombosis / occlusion
Stroke / cerebrovascular accident
Total occlusion of coronary artery

AP2929592 Rev. B

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