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The EmPro™ EPS/Nanoparasol™ EPS is indicated for use as a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the filter placement should be between 3.0 and 6.5 mm.

MicroVention's Embolic Protection System (EPS) is marketed under two names: EmPro™ Embolic Protection System and Nanoparasol™ Embolic Protection System. The Embolic Protection System (EPS) is designed to capture and remove dislodged debris during a carotid interventional procedure. It consists of three basic components and additional accessories: 1) An Embolic Protection Device (EPD) consisting of a nitinol braided mesh filter with an atraumatic distal tip built on an integrated .014" PTFE coated stainless steel capture delivery wire. 2) A 3.5F delivery catheter with 150 cm length. 3) A 5F retrieval catheter with 150 cm working length. Accessories include a wire introducer, EPD loading cover, sheath introducer and a torque device. Catheters are provided in two separate dispenser coils.

The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below: - · Adequate femoral venous access - Common carotid artery reference diameter of at least 6mm - · Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomopgraphy (CT) angiography or magnetic resonance (MR) angiography.

The ENROUTE® Transcarotid Neuroprotection System (Modified) is designed to provide direct transcarotid arterial access to the common carotid artery (CCA), provide introduction of diagnostic agents and therapeutic devices, and provide embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis. The ENROUTE Transcarotid NPS (Modified) is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. It has an integrated filter used to capture and contain embolic material liberated during the procedure. The ENROUTE Transcarotid NPS (Modified) consists of four primary components: the Transcarotid Arterial Sheath with Dilator, the Venous Return Sheath with Dilator, the Flow Controller and a 0.035" Extra Support J-Tip Guidewire. When assembled and inserted into the patient, the components of the ENROUTE Transcarotid NPS (Modified) create an arteriovenous shunt. When used in conjunction with occlusion of the proximal common carotid artery, the ENROUTE Transcarotid NPS (Modified) reverses the direction of blood flow in the internal carotid artery (ICA), shunting embolic particles away from the cerebral circulation, and into the venous circulation. Flow through the arteriovenous shunt is regulated by the Flow Controller.

ANGIOGUARD XP and ANGIOGUARD RX Emboli Capture Guidewire devices are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the site of filter basket placement should be from 3mm to 7.5mm.

Both the subject and predicate ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices consists of a guidewire with integrated emboli filter basket at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (overthe-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. The ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices have a filter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved.

The WIRION® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION® may be used with commercially available 0.014" guide wires.

WIRION® is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.

The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.

The Emboshield NAV 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 site of the Filtration Element should be between 2.5 and 7.0 mm.

The Emboshield NAVO Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during interventional procedures within carotid arteries or atherectomy in the arterial vasculature of the lower extremity. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element and RX Retrieval Catheter and ancillary items which include loading funnel, flushing syringes, introducer tool and torque devices.

WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a embolic protection system comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator. The WIRION™ is identical to the FDA cleared (K143570) WIRION device indicated for use in carotid artery stenting (CAS) procedures.

The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) is intended to provide transcarotid vascular access, introduction of diagnosic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below: Adequate femoral venous access; Common carotid artery reference diameter of at least 6 mm; Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography.

Silk Road Medical, Inc. is the manufacturer of a single use device intended to provide embolic protection during carotid artery angioplasty and stenting procedures. The ENROUTE Transcarotid NPS is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. It has an integrated filter used to capture and contain embolic material liberated during the procedure. Like the predicate device, the ENROUTE Transcarotid NPS consists of three primary components: the ENROUTE Transcarotid Arterial Sheath, the ENROUTE Venous Return Sheath, and the ENROUTE Flow Controller. The Subject Device offers an Angled-Tip configuration and a Straight Tip configuration of the Transcarotid Arterial Sheath. When assembled, the ENROUTE Transcarotid NPS creates an Arteriovenous Shunt. The Transcarotid Arterial Sheath is placed in the carotid artery below the carotid bifurcation. The Venous Return Sheath is placed into the femoral vein. The Arterial and Venous Sheaths are connected by the Flow Controller, thereby completing the Arteriovenous Shunt. When the carotid artery is occluded just proximal to the Transcarotid Arterial Sheath insertion site, the arterial/venous pressure gradient diverts or reverses blood flow in the internal carotid artery (ICA) and external carotid artery (ECA) thereby directing the blood from the cerebral arteries through the Transcarotid Arterial Sheath, through the Flow Controller with integrated filter, and out through the Venous Return Sheath into the venous circulation. The ENROUTE Transcarotid Arterial Sheath and ENROUTE Venous Return Sheath are constructed of stainless steel reinforced thermoplastic elastomers attached to hemostasis valve adaptors. The Angled-Tip Transcarotid Arterial Sheath configuration has a 15° bend at the distal tip whereas the Straight-Tip Transcarotid Arterial Sheath configuration has no bend at the distal tip. The ENROUTE Flow Controller consists of DEHP free PVC tubing with an integrated polyester filter and polycarbonate housing. A 90cm long 0.035" PTFE coated Nitinol with stainless steel coil J-Tip Guidewire is provided with the ENROUTE Transcarotid NPS. The quidewire is used to facilitate the insertion of the Transcarotid Arterial Sheath into the common carotid artery (CCA) and the Venous Return Sheath into the femoral vein. The ENROUTE Transcarotid NPS is an ethylene oxide sterilized, non-pyrogenic, singleuse prescription device.

The RX ACCUNET 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. The diameter of the site of filter basket placement should be between 3.25 mm and 7.0 mm.

The RX ACCUNET Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System, the RX ACCUNET Recovery Catheter, Shapeable Tip Design and the RX ACCUNET 2 Recovery Catheter, Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET Embolic Protection System is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside.one of the provided Recovery Catheters. Recovery Catheter selection is based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy. The change being made is to the formulation of an adhesive that is used to adhere two core subassemblies.

The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a embolic protection System comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator.