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Indications for Use: The ENROUTE® Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) 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 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.
Contraindications: The ENROUTE Transcarotid NPS is contraindicated for use in patients exhibiting the following conditions:
- Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated
- Patients with unresolved bleeding disorders
- Patients with severe disease of the ipsilateral common carotid artery
- Uncontrollable intolerance to flow reversal (i.e. pre-conditioning does not result in intolerance to vessel occlusion/flow reversal)
POTENTIAL PROCEDURE AND / OR DEVICE RELATED ADVERSE EVENTS Complications and adverse events can occur when using any embolic protection device in carotid artery stenting procedures. These complications include, but are not limited to: abrupt vessel closure; allergic reactions; aneurysm; angina / coronary ischemia; arteriovenous fistula; bacteremia or septicemia; bleeding from anticoagulant or antiplatelet medications; bradycardia / arrhythmia and other conduction disturbances; cerebral edema; cerebral hemorrhage; component damage; congestive heart failure; death; deployment and retrieval failure; distal embolization; drug reactions; embolism (which includes thrombus, plaque, air, device and / or component); emergent / urgent endarterectomy; fever; fluid overload; groin hematoma; headache; hemorrhage / hematoma; hemorrhagic stroke; hyperperfusion syndrome; hypertension / hypotension; infection / sepsis; ischemia / infarction of tissue / organ; ischemic stroke; intolerance to vessel occlusion and / or flow reversal; myocardial infarction; pain and tenderness; pseudoaneurysm; reduced blood flow; renal failure / insufficiency; restenosis of the stented artery; seizure; stent deformation; stroke or other neurological complications (e.g., paralysis, paraplegia or aphasia); surgery required due to device failure; temporary or total occlusion of the artery; thromboembolic episodes; thrombophlebitis; transient ischemic attacks (TIAs); vascular access complications (e.g., bleeding, vessel damage, pseudoaneurysm and infection); ventricular fibrillation; vessel spasm, dissection, rupture, or perforation; vessel thrombosis (partial blockage); unstable angina pectoris.
Indications for Use: The ENROUTE® Transcarotid Stent System used in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy, who require carotid revascularization and meet the criteria outlined below.
Patients with neurological symptoms and › 50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and › 80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND
Patients must have a vessel diameter of 4-9 mm at the target lesion, AND
Carotid bifurcation is located at minimum 5 cm above the clavicle to allow for placement of the ENROUTE Transcarotid NPS.
Please refer to Instructions for Use for indications, contraindications, warnings and precautions.
Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
Contraindictions: Use of the ENROUTE Transcarotid Stent System is contraindicated in the following patients:
- Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
- Patients in whom the ENROUTE Transcarotid NPS is unable to be placed.
- Patients with uncorrected bleeding disorders.
- Patients with known allergies to nitinol.
- Lesions in the ostium of the common carotid artery.
General Warnings
Only physicians who have received appropriate training for transcarotid stenting and who are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device.
The safety and efficacy of the ENROUTE Transcarotid Stent System have not been demonstrated with embolic protection systems other than the ENROUTE Transcarotid NPS. Use the ENROUTE Transcarotid Stent System only with the ENROUTE Transcarotid NPS.
The long term performance (> 3 years) of carotid stents has not yet been established.
As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm or rupture.
The stent may cause a thrombus, distal embolization or may migrate from the site of implant through the arterial lumen. Appropriate sizing of the stent to the vessel is required to reduce the possibility of stent migration (see Section 9.3 of these instructions). In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
Overstretching of the artery may result in rupture and life-threatening bleeding.
In patients requiring the use of antacids and/or H2-antagonists before or immediately after stent placement, oral absorption of antiplatelet agents (e.g. aspirin) may be adversely affected.
The appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure as suggested in Section 9.1 of these instructions.
In the event of complications such as infection, pseudoaneurysm or fistulization, surgical removal of the stent may be required.
Non-clinical testing has demonstrated that the ENROUTE Transcarotid Stent is MR Conditional. A patient with this device can be scanned safely in an MR system meeting the following conditions:
- Static magnetic field of 1.5-Tesla or 3-Tesla, only
- Maximum spatial gradient magnetic field of 4,000 Gauss/cm (40 Tesla/m) or less
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg (Normal Operating Mode).
Under the scan conditions defined above, the ENROUTE Transcarotid Stent is expected to produce a maximum temperature rise of 2.4°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 5 mm from the ENROUTE Transcarotid Stent when imaged with a gradient echo pulse sequence and a 3-Tesla MRI system. The artifact does obscure the device lumen.
Potential Adverse Events
Adverse Events (in alphabetical order) that may be associated with the use of the ENROUTE Transcarotid Stent System when used in conjunction with the ENROUTE Transcarotid NPS include, but may not be limited to (based upon clinical trial data for the PRECISE Stent System and the ANGIOGUARD XP Emboli Capture Guidewire and clinical trial data from the ROADSTER and PROOF studies):
Air embolism, Allergic/anaphylactoid reaction, Anemia, Aneurysm, Angina/coronary ischemia, Arrhythmia (including bradycardia, possibly requiring need for a temporary or permanent pacemaker), Arterial dissection, Arterial occlusion/restenosis of the treated vessel, Arterial occlusion/thrombus, at puncture site, Arterial occlusion/thrombus, remote from puncture site, Arteriovenous fistula, Atelectasis, Atrial Fibrillation, Bacteremia or septicemia, Cerebral edema, Congestive heart failure, Death, Embolization, arterial, Embolization, stent, Emergent repeat hospital intervention, Fever, Gastrointestinal disorders, GI bleeding from anticoagulation/antiplatelet medication, Hallucination, Hematoma bleed, access site, Hematoma bleed, remote site, Hemorrhage, Hyperperfusion syndrome, Hypotension/hypertension, Hypomagnesaemia, Hypophosphatemia, Infection, Intimal injury/dissection, Ischemia/infarction of tissue/organ, Local infection and pain at insertion site, Malposition (failure to deliver the stent to the intended site), Myocardial infarction, Nausea, Oxygen saturation decrease, Pain, Pseudoaneurysm, Rales, Renal failure, Respiratory Infection, Restenosis of the vessel (> 50% obstruction), Rhinorrhea, Seizure, Severe unilateral headache, Stent migration, Stent thrombosis, Stroke, Transient ischemic attack, Transient intolerance to reverse flow, Urinary tract infection, Vasospasm, Venous occlusion/thrombosis, at puncture site, Venous occlusion/thrombosis, remote from puncture site, Vessel rupture, dissection, perforation, Vomiting, Wheezing.
Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a physician. ENROUTE and the Silk Road Logo are registered trademarks of Silk Road Medical, Inc. CORDIS®, PRECISE® and ANGIOGUARD® are registered trademarks of Cordis Corporation.