MULTI-LINK PIXEL Coronary Stent System (U.S. and Canada)

Features

Tailored Performance for Small Vessels

In patients presenting with abrupt or threatened abrupt closure.

A combination of less metal (5-crest and .0039" strut thickness), low recoil, tailored compliance and S.T.E.P. Balloon Technology leverage the clinically proven MULTI-LINK design.


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Less Metal

  • 5-crest circumferential coverage offers optimal scaffolding.
  • .0039" strut thickness.
  • 5-crest corrugated ring design is based on the clinically proven 6-crest MULTI-LINK design to provide excellent scaffolding

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Low Recoil

  • Extremely low recoil for precise stent expansion.

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S.T.E.P. Balloon Technology

  • Minimizes the amount of vessel dilated outside the stent and provides uniform stent expansion.

Extend Your Reach to Small Vessels

With abrupt or threatened abrupt closure

Low profiles, 5F compatibility, great flexibility and GRIP Technology provide for superb delivery and cross.

Low Profiles

  • Improved deliverability and crossability for excellent lesion cross and recross.
  • Now it's easy to get where you are going.

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Superb Flexibility

  • Extremely flexible system with superb delivery even in tortuosity.
  • Optimized .0039" strut thickness.
  • Based on the clinically proven MULTI-LINK pattern.

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GRIP Technology

  • Promotes excellent stent retention and protects stent edges while on delivery system.

Hydrocoat Hydrophilic Coating

  • Superb lubricity and smooth delivery.

5F Compatibility

  • Optimal clearance inside the guiding catheter, and inside tight anatomy

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Clinical Data

Building on the Success of Our MULTI-LINK Design

180-day MULTI-LINK PIXEL Registry
  PIXEL Registry @ 180 Days
Pateints 150
Lesion Length (mm) 10.21 plus or minus 4.39 (n=140)1
ACC/AHA Lesion Class B2 and C 46.7% (70/150)
Stent Thrombosis (30 days) 0.7% (1/150)
MACEa (180 days)2 10.2% (15/147)
TSRb 8.8% (13/147)

Source: 180 d. report - data on file at Abbott Vascular
1 Not all post-procedural angiographic data available for all patients
2 3 Patients lost to follow-up between 30 and 80 days
aMACE = Death, MI (Q-wave MI and non-Q-wave) and TSR by CABG or PCI
bTSR = Target site revascularization

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Specifications

5F Compatibility
Optimal clearance in tight anatomy

Proximal and Distal Markers
Clearly indicate the position of the expanded stent and balloon working length

GRIP™ Technology
Optimal stent retention and edge protection

Lower Profiles
Improved deliverability and crossability for excellent lesion cross and recross

Hydrocoat Hydrophilic Coating
Superb lubricity and smooth delivery

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Indications and Important Safety Information

MULTI-LINK RX PIXEL Coronary Stent System

INDICATIONS

The MULTI-LINK PIXEL Coronary Stent Systems are indicated for improving coronary luminal diameter in patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length ≤ 25 mm) with reference vessel diameters from 2.0 mg to 2.5 mm.

CONTRAINDICATIONS

The MULTI-LINK PIXEL Coronary Stent Systems are contraindicated for use in:

WARNINGS AND PRECAUTIONS

WARNINGS

Stent Handling – Precautions

Stent Placement – Precautions

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:

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


AP2929596 Rev. B