Emboshield NAV6 Embolic Protection System
Emboshield NAV6 Embolic
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.*
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.
EMBOLIC PROTECTION DEVICE FOR BOTH LOWER EXTREMITY AND CAROTID ARTERIES
Captures Effectively to Minimize Downstream 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.*
- Platinum-tungsten 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.
- Continued wire access, after filter is fully retracted, allows for easy delivery of additional therapy.
Navigates Skillfully Through Carotid and Lower Extremity Vasculature*
- Various types of BareWires™—distal access, workhorse, and support—are designed for various carotid anatomies.
- They promote navigational success through torturous anatomy and challenging arches.
Is Compatible with Various Atherectomy Options4
- Emboshield NAV6™ EPS and BareWire™ are compatible with a variety of atherectomy types.
- BareWire™ is available in 190 cm and 315 cm lengths.
In carotid procedures, the Emboshield NAV6™ EPS is used during stenting with the RX Acculink™ Carotid Stent System and the Xact™ Carotid Stent System.
* Data on file at Abbott.
References
- Bioangiu et al. Comparative analysis of retrieved particulate debris after superficial femoral atherectomy using three different atherectomy methods. EuroIntervention, May 2012.
- 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.
- 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.
- Philips Turbo-Elite, Medtronic TurboHawk PPES, and Boston Scientific Jetstream XC and SC. Test(s) performed by and data on file at Abbott.
IMPORTANT SAFETY INFORMATION
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 NAV 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.
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The proprietary thin-wall technology and Terumo M Coat hydrophilic coating
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IMPROVED BACK UP SUPPORT*1
Catheter designed to use contralateral wall resulting in enhanced back-up support.
UNIVERSAL SHAPE (IKARI LEFT) *2
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Soft tip to reduce damage to the vessel wall
*1: Ikari Y, Nagaoka M, Kim JY, Moreno Y, Tanabe T. The physics of guiding catheters for the left coronary artery in transfemoral and trans-radial interventions. J Invasive Cardio. 2005 Dec; 17(12): 636-641.*2: Youssef AA, Hsieh YK, Cheng CI, We CJ. A single trans-radial guiding catheter for right and left coronary angiography and intervention. Euro intervention 2007; 3: 475-481.
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Sizes Available Item Code JL3.5/5F TCO06GC-F5JL350N JL3.5/6F TCO06GC-F6JL350N JL4.0/6F TCO06GC-F6JL400N JR3.5/5F TCO06GC-F5JR350N JR3.5/6F TCO06GC-F6JR350N JR4.0/5F TCO06GC-F5JR400N JR4.0/6F TCO06GC-F6JR400N JR4.0/7F TCO06GC-F7JR400N MULTIPURPOSE 6F TCO06GC-F6MP010N TR4.0/6F TCO06GC-F6TR400N Heartrail II is developed to maximize your back-up force when using right and left Ikari curves during transradial interventions and through its innovative 5-in-6 system.
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Radifocus™ Introducer II Standard Kit A
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45 cmEntry needle Plastic IV Catheter – 18G x 2 ½” (1.2 x 64 mm),
except for 4 Fr with 45 cm straight mini guidewire: 20G x 2″ (0.9 x 51 mm)
2.5 ml syringe is includedGuidewire compatibility 0.025″ (0.64 mm) for 4 Fr, straight mini guidewire type
0.035″ (0.89 mm) for all othersPackaging Tray A Kit content Sheath, dilator, plastic mini guidewire and plastic IV catheter (entry needle) Item specifications
Inner diameter Mini guidewire type 45 cm angled 45 cm straight 4 Fr RS+A40K10AQ RS+A40G10SQ 4 Fr RS*A40G10SQ RS*A40G05SQ 4 Fr RS*A40K10SQ RS*A40G07SQ 5 Fr RS*A50K10AQ RS*A50G07SQ 5 Fr RS+A50K10AQ RS+A50K10SQ 6 Fr RS+A60K10AQ RS+A60K10SQ 6 Fr RS*A60K10AQ RS*A60G07SQ 6 Fr — RS*A60G16SQZ 6 Fr — RS*A60K10SQ 6 Fr — RS+A50K10SQ 7 Fr — RS+A70K10SQ 7 Fr — RS*A70G07SQ 7 Fr — RS*A70K10SQ 8 Fr — RS+A80K10SQ 8 Fr — RS*A80K10SQ 9 Fr — RS*A90K10SQ 10 Fr — RS*A10K10SQ 11 Fr — RS*A11K10SQ A Kit includes: introducer sheath, dilator, mini Guide wire, entry venous catheter, 2.5 cc syringe
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C Kit includes: introducer sheath, dilator
R Kit includes: introducer sheath, dilator, mini Guide wire, 18 G x 2 3/4” / 1.2 x 70 mm entry metallic needle
Other code numbers are available on special demand. For any further information, please contact your Terumo local representative
Units per box: 5 for kits in tray and 10 for kits in pouch. -
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