FilterWire EZ™ Embolic Protection System

Overview

With its advanced technology designed for simplicity and effectiveness, the FilterWire EZ Embolic Protection System is intended to deliver efficient, predictable protection.

Product Details

 

To view product information for the FilterWire EZ Embolic Protection System specific to use in carotid arteries, click here.

Device Illustration

FilterWire EZ Schematic

Device Highlights

The FilterWire EZ System Minimum Landing Zone (distal edge of lesion to loop apex):
   - 2.25mm - 3.5mm: ≥ 2.5cm
   - 3.5mm - 5.5mm: ≥ 3.0cm

  1. Radiopaque Spring Tip (2.0cm and 3.0cm, respectively)
  2. 110 Micron Pore Filter
  3. Radiopaque Nitinol Loop
  4. Spinner Tube
  5. Proximal Stop
  6. PTFE Coated Wire (.014")

Product Information

Easy to Use
  • Reliable Wall Apposition – Self-conforming filter loop is designed to provide 360º apposition in both straight and curved anatomy.
  • Easy Delivery – Efficient design reduces preparation time and simplifies device deployment.
  • Efficient Debris Capture – Uniform, 110-micron-pore filter is designed to permit continuous blood flow while maintaining embolic capture efficiency.


Built-in Versatility
  • Dual-Indication Use – Approved for both saphenous vein graft (SVG) and carotid indications.
  • Simplified Filter Sizing – One product line provides coverage in vessels ranging between 2.25mm and 5.5mm for SVG procedures and between 3.5mm and 5.5mm for carotid procedures.


Clinically Effective
  • The BLAZE and BLAZE II registries achieved a low 6.7% and 3.8% MACE rate, respectively, and confirmed the safety and performance of the FilterWire System in SVGs.*

Additional Information

  • 6F Guide Catheter Compatible
  • Catalog Numbers and Descriptions:
    • H749 20100-190 0 FilterWire EZ System 190cm
    • H749 20100-300 0 FilterWire EZ System 300cm
    • H749 50100-150 0 EZ Bent Tip Retrieval Sheath

New 2.25mm - 3.5mm Device Now Available

  • H749 39071-190 0 FilterWire EZ System 2.25mm - 3.5mm, 190cm
  • H749 39071-300 0 FilterWire EZ System 2.25mm - 3.5mm, 300cm


*The BLAZE/BLAZE II registries showed low major adverse cardiac event (MACE) rates for the FilterWire EZ System. See BLAZE/BLAZE II trial designs for more information and definitions of MACE rates. BLAZE II adjusted 30-day MACE based on predicted values for missing CK-MBs is 4.6%.

Prescriptive Information

 

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Indications

The FilterWire EZ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.

The safety and effectiveness of this device as an embolic protection system have not been established in the cerebral vasculature, peripheral vessels other than carotid arteries, or in treating native coronaries, including acute myocardial infarction.

Contraindications

  • Patients with severe allergy to heparin
  • Patients with bleeding diathesis or other disorders that limit the use of anticoagulant therapy

Warnings

  • Only physicians thoroughly trained in percutaneous intravascular techniques and procedures should use the FilterWire EZ System (refer to Physician Training section).
  • The safety and effectiveness of coronary drug-eluting stents (DES) when used with embolic protection devices have not been established.
  • The safety and effectiveness of the FilterWire EZ System have not been demonstrated with carotid stents other than the Carotid WALLSTENT® Monorail® Endoprosthesis and Delivery System (Carotid WALLSTENT Endoprosthesis) and the NexStent® Carotid Stent and Monorail Delivery System (NexStent Carotid Stent).
  • The appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure to minimize the risk of embolism and thrombosis.

Adverse Effects

Possible adverse events associated with FilterWire EZ System use and application procedure include, but are not limited to, the following:
  • Angina
  • Bleeding complications
  • Bradycardia or arrhythmias, including ventricular fibrillation or tachycardia
  • Congestive heart failure
  • Damage to or dislocation of the implanted stent(s)
  • Death
  • Detachment and/or implantation of a component of the system
  • Drug reaction, allergic reaction to contrast media, medications or device materials
  • Embolization of air, tissue, thrombus or other embolic debris
  • Emergent surgery
  • End organ ischemia, vessel thrombosis or spasm
  • Hypotension/hypertension
  • Infection (local or systemic)
  • Myocardial infarction
  • No-reflow resulting from reduced blood flow through the FilterWire EZ System filter
  • Pseudoaneurysm
  • Puncture site complications (i.e., vessel occlusion, hemorrhage, hematoma, pseudoaneurysm or arteriovenous fistula)
  • Renal insufficiency, kidney failure, hematuria
  • Stroke/cerebrovascular accident (CVA), transient ischemic attack (TIA) or seizure
  • Vessel damage, dissection, occlusion, aneurysm, perforation, rupture or injury.
Adverse events experienced during clinical studies are presented in theClinical Study Overview sections.

Product Callouts

Directions for Use

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