NOTE: Results from clinical trials are not directly comparable. Information provided for educational purposes only.
The Emboshield NAV6™ Embolic Protection System, which includes BareWire™ Filter Delivery Wires, allows the guide wire to rotate and advance freely, independent of the Emboshield NAV6™ filter.*
The Emboshield NAV6™ EPS 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 carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
* Data on file at Abbott.
In carotid procedures, the Emboshield NAV6™ EPS is used during stenting with the RX Acculink™ Carotid Stent System and the Xact™ Carotid Stent System.
Embolic Protection Devices can add a layer of protection during endovascular procedures in the lower extremities or carotids. In the lower extremities, downstream complications can be minimized and in the carotids, the stroke rate can be reduced with the use of EPDs1.
Three trials evaluated carotid stenting with the Emboshield NAV6™ EPS and/or previous generation Abbott products.
Summary of Clinical Trial Data for Emboshield NAV6™ Embolic Protection System
| ACT I2 (n = 1,453; carotid stenting n = 1,089) Asymptomatic patients at standard risk for CEA |
CHOICE3 (n = 17,925) Symptomatic and asymptomatic patients at high risk for CEA |
PROTECT4 (n = 220) Symptomatic and asymptomatic patients at high risk for CEA |
|
|---|---|---|---|
| DSMI (30 Days) |
3.3% | 4.2% | 2.3% |
| DS (30 Days) |
2.9% | 3.8% | 1.8% |
| Death or Major Stroke (30 Days) |
0.6% | 1.4% | 0.5% |
| Freedom from Ipsilateral Stroke | 97.8% (30 Days – 5 Years) |
Not evaluated | 98.8% (31 Days – 3 Years) |
DS = Death or stroke DSMI = Death, stroke, or myocardial infarction CEA = Carotid endarterectomy
The primary aim of this prospective, multicenter trial was to compare the outcomes of stenting with embolic protection vs carotid endarterectomy.
Patients
The 1,453 patients were randomly assigned to the stenting group (n = 1,089) or the CEA group (n = 364), all of whom met the following criteria:
Findings
| ACT I Trial | ||
|---|---|---|
| Carotid Artery Stenting (CAS) | Carotid Endarterectomy | |
| Primary composite endpoint: DSMI (at 30 days) and ipsilateral stroke (31 days - 1 year) | 3.8% | 3.4% |
| Freedom from ipsilateral stroke (31 days - 5 years) | 97.8% | 97.3% |
| Freedom from clinically driven revascularization (5 years, p = 0.05) | 98.4% | 96.7% |
| 5 year survival | 87.1% | 89.4% |
The authors concluded that:
With 17,925 patients evaluated, the CHOICE trial represents the largest prospective, single-arm, adjudicated, multicenter CAS data set to date. The CHOICE study also provided additional post-market surveillance of RX Acculink™ Carotid Stent System and Abbott’s embolic protection systems.
Patients
Patient criteria included:
There were other notable aspects of the patient population:
Findings
The 30-day findings included:
| CHOICE Trial | ||
|---|---|---|
| All Patients (n = 17,925) |
Patients Age < 80 (n = 13,868) |
|
| DSMI | 4.2% | 3.4% |
| DS | 3.8% | 3.0% |
| Death or major stroke | 1.4% | 1.1% |
The investigators concluded that CAS is a viable option for patients at high risk for CEA. In addition, favorable outcomes were observed in patients < 80 years of age.
Investigators undertook the PROTECT trial (n = 220) in an effort to evaluate the outcomes with improved device technology.
Patients
The PROTECT trial included only patients at high surgical risk for CEA, and severe stenosis:
Findings
| PROTECT Trial | |
|---|---|
| DS (30 days) | 1.8% |
| DSMI (30 days) | 2.3% |
| Death or Major Stroke (30 days) | 0.5% |
| Freedom from Ipsilateral Stroke (31 days – 3 years) | 98.8% |
These data reveal improved outcomes compared to earlier high-risk CAS trials.
PROTECT Trial: Lower DSMI Rate Outcomes vs Other High Risk Carotid IDE Trials
NOTE: Results from clinical trials are not directly comparable. Information provided for educational purposes only.
FILTER
120-µm PORE SIZE
Effectively captures debris while also allowing blood flow
HIGH-STRENGTH NYLON FILTER MATERIAL
Is designed to enhance capture efficiency by maintaining wall apposition and protecting the vessel wall from direct contact with the nitinol frame
NON-THROMBOGENIC HYDROPHILIC COATING
Is designed to reduce platelet or protein adhesion
1. BAREWIRE™ TECHNOLOGY
Is a proprietary wire technology that enables guide wire-only access through the lesion and ensures stable filter position
2. PROXIMAL MARKER BAND
Includes proprietary radiopaque markers for smooth tracking through tortuous anatomy
3. NITINOL FRAME
Is designed for outstanding circumferential wall apposition—even on a bend—and collapses into a low-profile wrap down during filter retrieval
4. CENTERED WIRE DESIGN
Prevents filter bias against the vessel wall and allows effective capture in all vessel types
5. PLATINUM TUNGSTEN MARKERS
Are radiopaque markers to convey vessel apposition and deployment status
6. 1-MM PORE-FREE ZONE AT DISTAL TIP
Prevents extrusion of embolic material during blood flow
7. DISTAL MARKER BAND
Includes proprietary radiopaque markers for smooth tracking through tortuous anatomy
8. BAREWIRE™ 0.019” STEP
Acts as a distal stop for the Filtration Element
There are three types of BareWire™ delivery wires.
Distal Access: A soft BareWire™, it provides extra flexibility for successful access through torturous anatomy
Workhorse: Provides optimal flexibility and support for superb access through most anatomies
Support: Is designed to provide additional support for delivery of the filter in challenging arches
The deployment status and the vessel apposition can be visually confirmed because of the device’s radiopaque frame.
* Data on file at Abbott.
The streamlined Emboshield NAV6™ EPS prep procedure requires three steps. Refer to the Instructions for Use for additional information.
1 Flush in Two Places |
|
At the exit port of the delivery catheter |
 |
In the filter, to remove air bubbles |
 |
2 Pull the Filter into the Delivery Catheter |
|
Pull until the filter is completely inside the delivery catheter, at which point the gold marker is adjacent to the delivery catheter tip |
 |
3 Check the Gold Marker |
|
Visually check to ensure that the filter is fully loaded into the delivery catheter |
 |
| PART NUMBER | UNCONSTRAINED FILTER DIAMETER | VESSEL DIAMETER | WIRE LENGTH | MINIMUM SHEATH/GUIDE SIZE | FILTRATION ELEMENT LENGTH (cm) | CROSSING PROFILE (F) | MINIMUM SHEATH/GUIDE I.D. REQUIRED |
|---|---|---|---|---|---|---|---|
| 22437-19 (Small) | 5.0 mm | 2.5-4.8 mm | 190 cm | 5F / 6F | 1.9 | 2.8 | 0.070" |
| 22438-19 (Large) | 7.2 mm | 4.0-7.0 mm | 190 cm | 5F / 6F | 2.3 | 3.2 | 0.070" |
| CONSISTS OF 2 PRIMARY PACKS | |
|---|---|
| PRIMARY PACK Filtration System: |
PRIMARY PACK (1) RX Delivery Catheter, (1) Filtration Element, (1) BareWire™ Filter Delivery Wire (Workhorse, 190 cm), (1) Loading Funnel, (1) Introducer, (1) Torque Device, (1) Syringe with Flushing Tip |
| RX Retrieval Catheter: | (1) RX Retrieval Catheter, (1) Torque Device, (1) Syringe Flushing Tip |
| PART NUMBER | WIRE TYPE | WIRE LENGTH |
|---|---|---|
| 22439-19 | Distal Access | 190 cm |
| 22440-19 22440-31 |
Workhorse | 190 cm 315 cm |
| 22441-19 | Support | 190 cm |
**BareWires™ are sold in packs of five
Emboshield NAV6™ Embolic Protection SystemThe Emboshield NAV6™ 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 carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
The Emboshield NAV6™ Embolic Protection System is contraindicated for use in
Use of the device should be restricted to physicians trained to the specifics of the device and to the Instructions for Use. Operators must be knowledgeable of the current medical literature and familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid and lower extremity interventional procedures. |
Refer to instructions supplied with all interventional devices to be used with the Emboshield NAV6™ Embolic Protection System for their intended uses, contraindications, and potential complications.
The Emboshield NAV6™ System is supplied sterile. Do not use if the package has been opened or is damaged. Carefully inspect the system components prior to use to verify that they have not been damaged and that the size, shape and condition are suitable for the procedure for which they are to be used. A device or access device that is kinked or damaged in any way should not be used.
Safety and effectiveness of this device as an embolic protection system has not been established in the coronary or cerebral vasculature.
The safety and efficacy of the Emboshield NAV6™ Embolic Protection System has not been demonstrated with carotid stent systems other than the Xact™ or Acculink™ Carotid Stent Systems.
The safety and efficacy of the Emboshield NAV6™ Embolic Protection System has not been demonstrated with atherectomy devices other than Turbo-Elite‡ Laser Atherectomy Catheter, Jetstream‡ Single Cutter (SC) Atherectomy Catheter, Jetstream‡ eXpandable Cutter (XC) Atherectomy Catheter and TurboHawk‡ Peripheral Plaque Excision System.
The Emboshield NAV6™ device can only be used with the BareWire™ Filter Delivery Wire. Use of the device with any guide wire other than the BareWire™ Filter Delivery Wire will lead to loss of the Filtration Element during the procedure or an inability to retrieve the Filtration Element. |
To reduce the potential for the liberation of emboli during lesion crossing, the device should be carefully manipulated and not advanced against resistance.
If the Filtration Element moves into the stented vessel segment prior to retrieval, DO NOT RETRIEVE. Use the Retrieval Catheter to gently maneuver the Filtration Element distally until it is situated in an unstented portion of vessel. Retrieval should then proceed.
Maintain proper guiding catheter / sheath support throughout the procedure. Ensure that there is enough distance between the proximal tip of the Filtration Element and the most distal tip of any interventional device to be introduced over the Filter Delivery Wire to avoid engagement. The tip of a balloon catheter or a stent delivery system or an atherectomy device should not contact the Filtration Element. Failure to maintain adequate distance could result in inadvertent Filtration Element movement and Stent Delivery System tip / Filtration Element entanglement and / or Filtration Element /Stent entanglement if guide catheter or sheath prolapse occurs.
Precautions to prevent or reduce clotting should be taken when any interventional device is used. Flush or rinse all devices entering the vascular system with heparinized normal saline or alternative anticoagulant, prior to use.
The Emboshield NAV6™ Embolic Protection System must be used with a guiding catheter or introducer sheath to maintain adequate support for the BareWire™ Filter Delivery Wire throughout the procedure.
Venous access should be available during carotid stenting in order to manage bradycardia and / or hypotension by either pharmaceutical intervention or place of a temporary pacemaker, if needed.
Removal of the BareWire™ Filter Delivery Wire with the Emboshield NAV6™ Filtration Element through any interventional devices other than the Emboshield NAV6™ RX Retrieval Catheter has not been tested.
The minimum expanded stent internal diameter required for retrieval of a large embolic load is 2.5 mm.
As reported in the literature, the following adverse events are potentially associated with carotid stents and embolic protection systems:
Any adverse event occurring involving the Emboshield NAV6™ Embolic Protection System should be reported immediately to Abbott Vascular, Customer Service: 1-800 227-9902.
AP2946421-WBU Rev. C
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