Clinical Evidence for the Emboshield NAV6 Embolic Protection System | Abbott
CARDIOVASCULAR
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Emboshield NAV6 Embolic Protection System

Excellent Outcomes: Emboshield NAV6™ EPS Clinical Data

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 EPDs.1
 

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

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.5
  • 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.5

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.

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. 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.
  2. Wechsler, LR. Asymptomatic Carotid Stenosis Stenting v. Endarterectomy Trial (ACT I). ISC 2016.
  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. 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.
  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 Carotid Stent System Instructions for Use (IFU). Refer to IFU for additional information.
  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.

* 30-day death, stroke, and MI plus late (31–365 days) ipsilateral stroke

MAT-2200248 v1.0

Important Safety Information

IMPORTANT SAFETY INFORMATION
 

Rx Emboshield NAV6™ Embolic Protection System


Indications

The 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.
 

Contraindications

The Emboshield NAV6™ Embolic Protection System is contraindicated for use in

  • Patients in whom anticoagulant and / or antiplatelet therapy is contraindicated.
  • Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of the Guiding Catheter / Introducer Sheath, Embolic Protection System.
  • Patients with a known allergy or hypersensitivity to device materials (Nitinol, Nickel, Titanium) or contrast medium, who cannot be adequately premedicated.
  • Patients with uncorrected bleeding disorders.
  • Lesions in the ostium of the common carotid artery.
  • Inability to cross the lesion with the BareWire™ Filter Delivery Wire.
  • Diffusely diseased vessels where there is no disease-free section in which to deploy the Filtration Element
  • Insufficient straight section of vessel distal to the lesion to permit Filtration Element deployment.
     


Warnings

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

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.
 

Adverse Events

As reported in the literature, the following adverse events are potentially associated with carotid stents and embolic protection systems:

  • Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, stent material (Nitinol, Nickel, Titanium) and drug reactions to anticoagulation, or antiplatelet drugs
  • Vascular access complications which may require transfusion or vessel repair, including:
    • Bleeding (ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage)
    • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation/rupture, and laceration
    • Embolism (air, tissue, plaque, thrombotic material or device)
    • Thrombophlebitis
  • Target artery complications which may require additional intervention, including:
    • Total occlusion or abrupt closure
    • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation/rupture
    • Embolism (air, tissue, plaque, thrombotic material or device)
    • Stenosis or restenosis
    • Artery, stent, or filter thrombosis / occlusion thrombosis
    • Vessel spasm
  • Cardiac arrhythmias (including conduction disorders, atrial and ventricular arrhythmias)
  • Cardiac ischemic conditions (including myocardial ischemia, myocardial infarction, and unstable or stable angina pectoris)
  • Stroke/Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA)
  • System organ failures:
    • Cardio Pulmonary failure
    • Renal failure / insufficiency
  • Blood cell disorders including heparin induce thrombocytopenia and other coagulopathy
  • Hypotension/hypertension
  • Peripheral nerve injury
  • Other ischemic conditions/infarct
  • Infection - local and systemic (including postprocedural)
  • Nausea and vomiting
  • Chest pain
  • Edema/Cerebral edema and fluid overload
  • Fever
  • Pain, including headache
  • Hyperperfusion syndrome
  • Other neurologic and systemic complications
  • Cerebral hemorrhage
  • Death

Any adverse event occurring involving the Emboshield NAV6™ Embolic Protection System should be reported immediately to Abbott Vascular, Customer Service: 1-800 227-9902.

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