Tests performed by and data on file at Abbott.
The XACT™ Carotid Stent System (XACT™), used in conjunction with the Emboshield™ family of Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the criteria outlined below:
Patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography), located between the origin of the common carotid artery and the intra-cranial segment of the internal carotid artery AND
Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion.
Contraindications associated with angioplasty must be considered when using the XACT™ Carotid Stent System. These include, but are not limited to:
Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device.
Refer to instructions supplied with all interventional devices to be used with the XACT™ Carotid Stent System for their intended uses, contraindications, and potential complications.
The safety and efficacy of the XACT™ Carotid Stent System has not been demonstrated with embolic protection systems other than the Emboshield™ Embolic Protection System.
The long-term performance (> 1 year) of the XACT™ Carotid Stent System has not been established.
As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm, or rupture.
Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures.
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 these instructions. Special consideration should be given to those patients with recently active gastritis or peptic ulcer disease.
When multiple stents are required, stent materials should be of similar composition.
The safety and effectiveness of the XACT™ Carotid Stent System has NOT yet been established in patients with the characteristics noted below.
The safety and effectiveness of concurrent treatment of lesions in patients with bilateral carotid artery disease have not been established.
PRECAUTIONS
Carefully inspect device 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 which is kinked or damaged in any way should not be used. If pouch is damaged do not use.
Confirm the compatibility of the XACT™ Stent Delivery System with the interventional devices before actual use.
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 sterile isotonic heparinized saline prior to use.
Do not remove the stent from its delivery system as removal may damage the stent. The stent and delivery system are intended to be used in tandem. If removed, the stent cannot be put back on the delivery system.
The delivery system should not be used in conjunction with other stents.
To reduce the potential for the liberation of emboli during lesion crossing, the device should be carefully manipulated and not advanced against resistance.
During stent placement, 1.5 cm of vessel should be left between the distal margin of the stent and the Filtration Element. The stent delivery system should not contact the Filtration Element.
Venous access should be available during carotid stenting in order to manage bradycardia and / or hypotension by either pharmaceutical intervention or placement of a temporary pacemaker, if needed.
The device must only be flushed using the 3-ml syringe and flushing tip provided.
The outside diameter of the Outer Sheath is 5.7 Fr. An appropriate sized sheath / guiding catheter should be selected based on this diameter.
Do not use a prepared XACT™ Carotid Stent System if the stent is not fully constrained within the Delivery System.
Do not use if the stent is partially deployed.
If, after preparation, a gap between the catheter tip and the outer sheath exists, rotate the Deployment Actuator in an anti-clockwise direction until the gap is closed.
Advancement and deployment of the XACT™ Carotid Stent System should only be performed under fluoroscopic observation.
Do not advance any component, or section thereof, of the XACT™ Carotid Stent System against significant resistance. The cause of any resistance should be determined via fluoroscopy and remedial action taken.
Do not attempt to reposition the Delivery System once the stent has made contact with the vessel wall.
Do not torque the XACT™ Carotid Stent System.
If more than one stent is required to cover the lesion, or if there are multiple lesions, the distal lesion should be stented first, followed by stenting of the proximal lesion.
If overlap of sequential stents is necessary, the amount of overlap should be kept to a minimum.
Non-clinical testing has demonstrated that the XACT™ Carotid Stent is MR Conditional. It can be scanned safely under the conditions listed in the Instructions for Use.
As reported in the literature, the following adverse events are potentially associated with carotid stents and embolic protection systems:
MAT-2006273 v3.0
The RX Acculink™ Carotid Stent System, used in conjunction with the Abbott Vascular embolic protection system specified below, is indicated for the treatment of patients at high and standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below:
| High Risk | Standard Risk | |
|---|---|---|
| Embolic Protection System | Abbott Vascular's Accunet™ or Emboshield™ Family | |
| With neurological symptoms | ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiogram | ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram |
| Without neurological symptoms | ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiogram | ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram |
| Reference vessel diameter | Must be within 4.0 mm – 9.00 mm at the target lesion | |
The RX Acculink™ Carotid Stent System is contraindicated for use in:
Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid stent placement should use this device.
General
Refer to the Instructions for Use supplied with any interventional devices to be used in conjunction with the RX Acculink™ Carotid Stent System for their intended uses, contraindications, and potential complications.
The safety and efficacy of the RX Acculink™ Carotid Stent System have not been demonstrated with embolic protection systems other than Abbott Vascular’s Accunet™ or Emboshield™ family of Embolic Protection Systems (EPS). Refer to the Instructions for Use document for the Embolic Protection System that will be used for specific device instructions.
Clinical study results suggest lower event rates when the RX Acculink™ Carotid Stent System is used in conjunction with an embolic protection device.
The long-term performance (> 3 years) of the Acculink™ Carotid Stent has not been established.
As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm, or rupture.
Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures.
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 these instructions. Special consideration should be given to those patients with recently active gastritis or peptic ulcer disease.
When multiple stents are required, stent materials should be of similar composition.
Patient Selection
The safety and effectiveness of the RX Acculink™ Carotid Stent System have NOT yet been established in patients with the characteristics noted below.
Patient Characteristics
Lesion Characteristics:
Access Characteristics:
The safety and effectiveness of concurrent treatment of lesions in patients with bilateral carotid artery disease have not been established.
Device Use
This device is intended for single-use only. Do not reuse. Do not resterilize, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.
Do not use the product after the "Use by" date specified on the package.
Do not use the product if the temperature indicator on inner pouch is black.
Maintain the patient’s Activated Clotting Time (ACT) at > 250 seconds throughout RX Acculink™ Carotid Stent System usage to prevent thrombus formation on the device.
Maintain continuous flush while removing and reinserting devices on the guide wire. Perform all exchanges slowly to prevent air embolism or trauma to the artery.
Caution should be used if pre-dilating the lesion without embolic protection as this may increase the risk of an adverse outcome.
Implanting a stent may lead to dissection of the vessel distal and / or proximal to the stent and may cause acute closure of the vessel, requiring additional intervention (carotid endarterectomy, further dilatation, or placement of additional stents).
The stent may cause a thrombus, distal embolization or may migrate from the site of implant down the arterial lumen. Appropriate sizing of the stent to the vessel is required to reduce the possibility of stent migration. In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
In the event of complications such as infection, pseudoaneurysm or fistulization, surgical removal of the stent may be required.
Overstretching of the artery may result in rupture and life-threatening bleeding.
If a filter-based embolic protection system (EPS) is used, allow for and maintain adequate distance between the RX Acculink™ Carotid Stent System and the EPS to avoid potential filter engagement with the RX Acculink™ Carotid Stent System tip and / or filter entanglement with the deployed stent. If filter engagement and / or entanglement or filter detachment occurs, surgical conversion or additional catheter based intervention may be required.
Ensure optimal positioning of the stent prior to deployment. Once deployment is initiated, the stent cannot be repositioned or recaptured. Stent retrieval methods (use of additional wires, snares and / or forceps) may result in additional trauma to the carotid vasculature and / or the vascular access site. Complications may include death, stroke, bleeding, hematoma or pseudoaneurysm.
Stent Handling – Precautions
Carefully inspect the RX Acculink™ Carotid Stent System to verify that the device has not been damaged in shipment. Do not use damaged equipment.
The delivery system has an internal hypotube. Take care to avoid unnecessary handling, which may kink or damage the delivery system. Do not use if device is kinked.
Do not expose the delivery system to organic solvents (e.g. alcohol) as structural integrity and / or function of the device may be impaired.
Do not remove the stent from its delivery system as removal may damage the stent. The stent on the delivery system is intended to perform as a system. If removed, the stent cannot be put back on the delivery system.
The delivery system should not be used in conjunction with other stents.
Special care must be taken not to handle or in any way disrupt the stent on the delivery system. This is most important during catheter removal from packaging, mandrel removal, placement over the guide wire, and advancement through a Rotating Hemostatic Valve (RHV) adapter and guiding catheter hub.
Do not hold the sheath or stent during mandrel removal.
Stent Placement – Precautions
Use with bleedback control hemostatic valves is not recommended.
The RX Acculink™ Carotid Stent System is not compatible with any guide wire larger than 0.014” (0.36 mm).
Leave the safety lock closed until the stent is ready to deploy.
The RX Acculink™ Carotid Stent System must be used with a guiding catheter or introducer sheath to maintain adequate support of the 0.014” (0.36 mm) guide wire throughout the procedure.
For best device performance, the guide wire exit notch should remain within the guiding catheter or sheath.
Ensure the stent system is fully flushed with heparinized saline prior to use. Do not use the delivery system if flush is not observed exiting at the distal end of the sheath.
Do not attempt to pull a partially expanded stent back through the guiding catheter or sheath; dislodgment of the stent from the delivery system may occur.
Venous access should be available during carotid stenting to manage bradycardia and / or hypotension by either pharmaceutical intervention or placement of a temporary pacemaker, if needed.
When catheters are in the body, they should be manipulated only under fluoroscopy. Radiographic equipment that provides high quality images is needed.
The delivery system is not designed for use with power injection. Use of power injection may adversely affect device performance.
If resistance is met during delivery system introduction, the system should be withdrawn and another system used.
Prior to stent deployment, remove all slack from the delivery system.
When more than one stent is required to cover the lesion, or if there are multiple lesions, the distal lesion should be stented first, followed by stenting of the proximal lesion. Stenting in this order obviates the need to cross the proximal stent for placement of the distal stent and reduces the chance of dislodging stents that have already been placed.
If overlap of sequential stents is necessary, the amount of overlap should be kept to a minimum (approximately 5 mm). In no instance should more than 2 stents overlap.
Post-Implant – Precautions
Care must be exercised when crossing a newly deployed stent with other interventional devices to avoid disrupting the stent geometry and placement of the stent.
In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
MRI Compatibility
Non-clinical testing has demonstrated that the Acculink™ Carotid Stent, in single and overlapped configurations up to 75 mm in length, is MR Conditional. Patients with this implant can be scanned safely under the following conditions:
Under the scan conditions defined above, the Acculink™ Carotid Stent is expected to product a maximum temperature rise of less than 3.4°C after 16 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extents approximately 5 mm from the Acculink™ Carotid Stent when imaged with a spin echo pulse sequence and a 3.0 Tesla MRI system.
Based on the literature, and on clinical and commercial experience with carotid stents and embolic protection systems, the following alphabetical list includes possible adverse events associated with use of these devices:
MAT-2006244 v2.0
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.
The Emboshield NAV6™ Embolic Protection System is contraindicated for use in
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 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. As reported in the literature, the following adverse events are potentially associated with carotid stents and embolic protection systems: Any adverse event occurring involving the Emboshield NAV6™ Embolic Protection System should be reported immediately to Abbott Vascular, Customer Service: 1-800 227-9902.
Precautions
Potential Adverse Events
MAT-2208561 v2.0
MAT-2113533 v1.0
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