22437-19: Abbott Emboshield NAV6 Embolic Protection System: 5mm x 190cm

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Abbott Emboshield NAV6 Embolic Protection System

The Abbott Emboshield NAV6 Embolic Protection System 22437-19, a filter kit designed for effective management of carotid artery stenting procedures. Engineered by Abbott, a global leader in cardiovascular innovation, this bare-wire system captures and removes embolic debris with a low-profile, independent filter, ensuring vessel protection during stent deployment. Ideal for healthcare professionals performing transfemoral or transcarotid artery revascularization (TCAR) in standard and high-risk patients, this sterile, single-use kit delivers reliable navigation and secure outcomes.

The Emboshield NAV6 is Abbott Vascular's sixth generation in embolic protection devices.  This BareWire system allows wire movement independent of the filter, with an advanced filter design for enhanced capture efficiency and flow preservation.

Product Code: 22437-19

• Embolic Protection System
• Unconstrained Filter Diameter: 5mm
• Vessel Diameter: 2.5-4.8mm
• Guide Wire Length: 190cm
• Minimum Sheath/Guide Size: 5F/6F
• Minimum Sheath/Guide I.D. Required: 0.070"
• Filtration Element Length: 1.9cm
• Crossing Profile: 2.8F
• Material: Nitinol and Polyurethane Filter
• Design: Bare-Wire, Independent Low-Profile Filter
• Application: Carotid Artery Stenting (≥50% Symptomatic, ≥70% Asymptomatic)
• Single-Use, Disposable
• Sterile

Contents

• Primary Pack, Filtration System: RX Delivery Catheter, Filtration Element, BareWire™ Filter Delivery Wire (Workhorse, 190 cm), Loading Funnel, Introducer, Torque Device, Syringe with Flushing Tip
• Primary Pack, RX Retrieval Catheter: RX Retrieval Catheter, Torque Device, Syringe Flushing Tip

Key Specifications

• Brand: Abbott Cardiovascular
• Category: Peripheral Intervention
• Type: Embolic Capture System
• FDA Product Code: NTE
• FDA Product Code Name: Temporary Carotid Catheter for Embolic Capture
• GMDN Term Name: Embolic Protection Filtering Guidewire
• GMDN Term Definition: A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.

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.
   

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