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CARDIOVASCULAR
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CAPTURE WITH CONFIDENCE
Indicated for Carotids and Lower Extremities

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, minimizing filter movement during the case.*

 

* Data on file at Abbott.

Embolic Protection Device for Both Lower Extremity and Carotid Arteries

Captures Effectively to Minimize Complications1-3

  • Centered wire design prevents bias against the vessel wall for effective debris capture.*
  • Circumferential nitinol frame maintains optimal wall apposition, even on a bend.4
  • Frame coils provide excellent visibility.*
  • Two sizes allow for easy selection and minimal lab inventory.

Limits Filter Movement and Maintains Wire Access Through Innovative BareWire™ Design*

  • The unique BareWire™ technology allows the wire to rotate and advance freely, independently of the filter.
  • The filter is designed to stay in place during device delivery.4
  • Continued wire access, after filter is fully retracted, allows for easy delivery of additional therapy.4
  • They promote navigational success through torturous anatomy and challenging arches.

Navigates Skillfully Through Carotid and Lower Extremity Vasculature*

  • Various types of BareWires™—distal access, workhorse, and support—provide navigational success through various types of tortuous and challenging anatomy.
  • BareWire™ is available in 190 cm and 315 cm lengths.

Is Compatible with Various Atherectomy Options5

  • Emboshield NAV6™ EPS and BareWire™ are tested to be compatible with Philips Turbo-Elite, Medtronic TurboHawk PPES, and Boston Scientific Jetstream XC and SC.

In carotid procedures, the Emboshield NAV6™ EPS is used during stenting with the RX Acculink™ Carotid Stent System and the Xact™ Carotid Stent System.

  • References
    * Data on file at Abbott.
    1. Bioangiu et al. Comparative analysis of retrieved particulate debris after superficial femoral atherectomy using three different atherectomy methods. EuroIntervention, May 2012.
    2. Bioangiu et al. Analysis of Retrieved Particulate Debris after Superficial Femoral Artery (SFA) Atherectomy Using the Pathway Jetstream G3 device. CCI, May 2011, 77(2) p. S57.
    3. Mendes et al. Clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices. JVS, February 2014, 59(2), 359-367.
    4. Test(s) performed by and data on file at Abbott.
    5. Philips Turbo-Elite, Medtronic TurboHawk PPES, and Boston Scientific Jetstream XC and SC. Test(s) performed by and data on file at Abbott.

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.

Excellent Outcomes: Emboshield NAV6™ EPS Clinical Data

Clinical Findings in Brief

Three trials evaluated carotid stenting with the Emboshield NAV6™ EPS and/or previous generation Abbott products.

  • ACT I: Asymptomatic Carotid Trial I
  • CHOICE: Carotid Stenting for High Surgical-Risk Patients; Evaluating Outcomes Through the CollectIon of Clinical Evidence
  • Protect: Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (CEA)

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

ACT I Trial2,5

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:

  • Asymptomatic, severe (> 70%) carotid stenosis
  • ≤ 79 years of age
  • Standard risk for CEA surgical complications

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:

  • There were no significant differences in long-term (5-year) rates of stroke and survival between the two groups in this large randomized trial.
  • CAS was found to be noninferior to CEA for the primary composite end point: DSMI within 30 days; or ipsilateral stroke within 1 year post procedure.

CHOICE Trial3

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:

  • Severe stenosis of ≥ 50% for symptomatic patients and ≥ 80% for asymptomatic patients
  • High surgical risk for CEA

There were other notable aspects of the patient population:

  • 22.6% who were age ≥ 80
  • 24.4% who had heavy calcification at the target site

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.

PROTECT Trial4

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:

  • ≥ 50% for symptomatic patients
  • ≥ 80% for asymptomatic patients

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

PROTECT, with Abbott EPS: lower DSMI vs other trials

NOTE: Results from clinical trials are not directly comparable. Information provided for educational purposes only.

Lower Extremity Real World Data Analysis15

The Lower Extremity Real World Data Analysis is a prospective analysis of real-world data collected from 162 patients receiving embolic protection with Emboshield NAV6™ during atherectomy for femoral popliteal lesions in real-world clinical practice.

The primary analysis outcome was freedom from major adverse events (MAE) at 30 days, which was compared against a performance goal derived from MAE rates of similar devices used in the same anatomy.

Patients

Patient criteria:

  • Patients with symptomatic lower extremity PAD, which includes femoropopliteal lesions above the P2 segment and all TASC classifications, who received atherectomy in conjunction with Emboshield NAV6™ at the Mount Sinai Health Center between January 2014 and October 2015. Patients with critical limb ischemia or inflow disease, including the iliac, were excluded

Patients were treated per standard of care and choice of atherectomy, atherectomy device, use of filter, and filter type was at the discretion of the operator.

Findings

All Emboshield NAV6™ filters were delivered successfully, and there were no reports of device malfunction. One complication, a perforation caused by migration of the wire in the filter, occurred. The complication was treated without sequelae. Macroemboli was present in approximately 60% of cases, and filter overflow occurred in 10.5% of cases.

The 30-day freedom from MAE rate was 92.0%, in which the lower limit of the two-sided 95% confidence interval was 86.7%, meeting the pre-specified PG of 83%.

Freedom from Major Adverse Events Rate vs. Performance Goal

Primary Endpoint Performance Goal Emboshield NAV6
(N = 162)
Freedom from MAE
[95% Confidence Interval]1
83% 92.0% (149/162)
[86.7%, 95.7%]
  • References

    1. Banerjee A, Sarode K, Mohammad A, et al. Safety and Effectiveness of the Nav-6 Filter in Preventing Distal Embolization During Jetstream Atherectomy of Infrainguinal Peripheral Artery Lesions. J Invasive Cardiol. 2016;28(8):330-333. Kastrup, et al. Early Outcome of Carotid Angioplasty and Stenting With and Without Cerebral Protection Devices: A Systematic Review of the Literature. Stroke, Mar 2003, 34(3):813-9.
    2. Rosenfield K, Matsumura JS, Chaturvedi S, et al. Randomized trial of stent versus surgery for asymptomatic carotid stenosis. N Engl J Med. 2016;374(11):1011-1120.
    3. Metzger DC. The CHOICE prospective trial: carotid stenting in a post-market setting. VIVA 2013.
    4. Matsumura JS, Gray W, Chaturvedi S, et al. Results of carotid artery stenting with distal embolic protection with improved systems: Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) trial. J Vasc Surg. 2012; 55(4):968-976.e5.
    5. Wechsler, LR. Asymptomatic Carotid Stenosis Stenting v. Endarterectomy Trial (ACT I). ISC 2016.
    6. Yadav et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004;351:1493-501.
    7. Gray et al. Protected carotid stenting in high-surgical-risk patients: The ARCHeR results. JVS 2006;44(2) 258-68.
    8. Xact Instructions for Use. Data on file at Abbott.
    9. Iyer et al. Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ: 1-year outcomes in the BEACH Pivotal Group. J Am Coll Cardiol. 2008 Jan 29;51(4):427-34
    10. Safian et al. Protected carotid stenting in high-risk patients with severe carotid artery stenosis. J Am Coll Cardiol. 2006;47:2384-2389.
    11. Higashida et al. Evaluation of the Medtronic Exponent Self-Expanding Carotid Stent System With the Medtronic Guardwire Temporary Occlusion and Aspiration System in the Treatment of Carotid Stenosis. Stroke. 2010 Feb;41(2):e102-9.
    12. Hopkins et al. Carotid artery revascularisation in high-surgical-risk patients with the NexStent and the FilterWire EX/EZ: 3-year results from the CABERNET trial. EuroIntervention. 2010;5:917-924.
    13. Clair et al. Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30-day outcomes in the EMPiRE Clinical Study. Catheter Cardiovasc Interv. 2011 Feb 15;77(3):420-9.
    14. Ansel et al. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial. Catheter Cardiovasc Interv. 2010;76:1-8.
    15. Emboshield NAV6 Instructions for Use. Data on File at Abbott.
    * 30-day death, stroke, and MI plus late (31–365 days) ipsilateral stroke

Unique Features: Filter And BareWire™ Delivery Wires*

Filter

  • 120-µm PORE SIZE
    Effectively captures debris while also allowing blood flow

  • HIGH-STRENGTH 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 particulates

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 indicating the proximal end of the filter

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. FILTER FRAME MARKER
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

Delivery Wires For Flexibility And Support

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

Filter Visibility

The deployment status and the vessel apposition can be visually confirmed because of the device’s radiopaque frame.

Fully Deployed
Fully Captured

* Data on file at Abbott.

System Utilization: Preparation, Delivery, and Retrieval

Straightforward Preparation

The streamlined Emboshield NAV6™ EPS preparation 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

Gold marker must be next to delivery catheter tip

3 Check the Gold Marker

Visually check to ensure that the filter is fully loaded into the delivery catheter

Gold marker must be next to delivery catheter tip

Instructional Videos

Video: preparing to use Emboshield NAV<sup>6</sup>™ EPS
Streamlined 3-step preparation
Exchange of the BareWire™ from
standard 190 cm to longer 315 cm
Device deployment
Device retrieval

Ordering Information

Emboshield NAV6™ Embolic Protection System

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
22442-19 (Small) 5.0 mm 2.5-4.8 mm 190 cm 5F / 6F 1.9 2.8 0.070"
22443-19 (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:
CONTENT
(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

BareWire™ Filter Delivery Wires (0.014”)*

PART NUMBER WIRE TYPE WIRE LENGTH
22444-19 Distal Access 190 cm
22445-19
22445-31
Workhorse 190 cm
315 cm
22446-19 Support 190 cm

**BareWires™ are sold in packs of five

MAT-2002311 v1.0

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