Silk Road Medical ENROUTE Transcarotid Stent System Instructions For Use Manual

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Instructions for Use

Silk Road Medical ENROUTE® Transcarotid Stent System

READ ALL INSTRUCTIONS CAREFULLY. Failure to properly follow the instructions, warnings and precautions may

lead to serious consequences or injury to the patient.

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.

Use only with ENROUTE Transcarotid Neuroprotection System (NPS).

EO STERILE. ENROUTE Transcarotid Stent System is sterilized with ethylene oxide (EO) gas.

Non‐pyrogenic.

DO NOT USE THIS PRODUCT WITH POWER INJECTION SYSTEMS.

FOR ONE USE ONLY.

DO NOT RESTERILIZE.

DO NOT USE THIS PRODUCT PAST ITS EXPIRATION DATE.

THIS PRODUCT IS RADIOPAQUE.

STORE IN A COOL, DARK, DRY PLACE.

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Summary of Contents for Silk Road Medical ENROUTE Transcarotid Stent System

Page 1 Instructions for Use Silk Road Medical ENROUTE® Transcarotid Stent System READ ALL INSTRUCTIONS CAREFULLY. Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient. 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. Use only with ENROUTE Transcarotid Neuroprotection System (NPS). EO STERILE. ENROUTE Transcarotid Stent System is sterilized with ethylene oxide (EO) gas. Non‐pyrogenic. DO NOT USE THIS PRODUCT WITH POWER INJECTION SYSTEMS. FOR ONE USE ONLY. DO NOT RESTERILIZE. DO NOT USE THIS PRODUCT PAST ITS EXPIRATION DATE. THIS PRODUCT IS RADIOPAQUE. STORE IN A COOL, DARK, DRY PLACE. ...
Page 2 Caution: Federal law restricts this device to sale by or on the order of a physician Instructions for Use, ENROUTE Transcarotid Stent System, Table of Contents 1.0 Device Name 2.0 Description 3.0 Indications for Use 4.0 Contraindications 5.0 Warnings 5.1 General Warnings 5.2 Patient Selection Warnings 5.3 Device Use Warnings 6.0 Precautions 6.1 Stent Handling Precautions 6.2 Stent Placement Precautions 6.3 Post Stent Placement Precautions 6.4 MRI Safety Information 7.0 Adverse Events 7.1 Observed Adverse Events – Clinical Studies 7.2 ROADSTER Study – Sub‐Study of Patients Treated with a Combination of the PRECISE Stent System and the ENROUTE Transcarotid Neuroprotection System ...
Page 3 7.3 PROOF Pivotal Study – Sub‐Study of Patients Treated with a Combination of the PRECISE Stent System and the ENROUTE Transcarotid Neuroprotection System 7.4 Potential Adverse Events 7.5 Device Related Adverse Event Reporting 8.0 Clinical Study Information 8.1 The ROADSTER Study 9.0 Directions for Use 9.1 Peri‐Procedural Care 9.2 Pre‐Procedure 9.3 Device Selection and Preparation 9.4 Stent Deployment Procedure 10.0 Disclaimer of Warranty and Limitation of Remedy 11.0 License and Patent Disclosure 1.0 Device Name The device brand name is the ENROUTE® Transcarotid Stent System. 2.0 Description The ENROUTE Transcarotid Stent System consists of a nitinol self‐expanding stent preloaded on a 5F (.065" / 1.65 mm) or 6F (.078" / 1.98 mm) sheathed delivery system. The rapid exchange delivery system consists mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy Borst valve. The inner shaft consists of a support member and wire lumen. The proximal portion of the support member is comprised of a hub connected to a stainless steel wire and hypotube and distally of a stainless steel coil. The wire lumen originates distally in a catheter tip and terminates proximally at a guidewire exit port designed to accept a .014" (0.36 mm) guidewire. The outer sheath has a proximal shaft and distal outer sheath with a nominal working length of 57 cm. The self‐ expanding ENROUTE Transcarotid Stent System is constrained within the space between the inner shaft and the distal outer sheath, located between distal and proximal stent markers on the inner shaft. The stent expands to its unconstrained diameter when released from the deployment catheter into the carotid artery. Upon deployment, ...
Page 4 Figure 1. ENROUTE TRANSCAROTID STENT SYSTEM 1. Tuohy Borst valve 2. Hypotube 3. Coil 4. Catheter Inner Shaft Tip 5. Inner Shaft Hub 6A. Proximal Shaft 6B. Distal Outer Sheath 7. Outer Sheath Luer Hub 8. Pod Housing Crimped Stent 9. Tuohy Borst Y‐Connection 10. Proximal Inner Shaft Marker (Stop) Marks 11. Outer Sheath Radiopaque Marker 12. Proximal Valve End 13. Distal Inner Shaft Stent Marker 14. Coil Sleeve 15. Wire Lumen 16. Guidewire Exit Port The ENROUTE Transcarotid Stent System is provided as noted in Table 1 below. ...
Page 5 Table 1 ENROUTE Transcarotid Stent System 57 cm Working Length Guidewire Lumen: Accepts .014” (0.36 mm) Guidewire For use with ENROUTE Transcarotid Arterial Sheath (8F ID, 2.7 mm) .065" (1.65 mm) UNCONSTRAINED STENT CROSSING PROFILE ENROUTE DIMENSIONS CODES Diameter x Length (mm) SR‐0520‐CS 5 x 20 5F (.078", 1.98 mm) SR‐0530‐CS 5 x 30 5F (.078", 1.98 mm) SR‐0540‐CS 5 x 40 5F (.078", 1.98 mm) SR‐0620‐CS 6 x 20 5F (.078", 1.98 mm) SR‐0630‐CS 6 x 30 5F (.078", 1.98 mm) SR‐0640‐CS 6 x 40 5F (.078", 1.98 mm) SR‐0720‐CS 7 x 20 5F (.078", 1.98 mm) SR‐0730‐CS 7 x 30 5F (.078", 1.98 mm) SR‐0740‐CS 7 x 40 5F (.078", 1.98 mm) SR‐0820‐CS ...
Page 6 3.0 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. 1. 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 2. Patients must have a vessel diameter of 4‐9 mm at the target lesion, AND 3. Carotid bifurcation is located at minimum 5 cm above the clavicle to allow for placement of the ENROUTE Transcarotid NPS. 4.0 Contraindications Use of the ENROUTE Transcarotid Stent System is contraindicated in the following patients: 1. Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated. 2. Patients in whom the ENROUTE Transcarotid NPS is unable to be placed. 3. Patients with uncorrected bleeding disorders. 4. Patients with known allergies to nitinol. 5. Lesions in the ostium of the common carotid artery. 5.0 Warnings 5.1 General Warnings 1. 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. 2. 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. 3. The long term performance (> 3 years) of carotid stents has not yet been established. 4. As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm or rupture. 5. 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. 6. Overstretching of the artery may result in rupture and life‐threatening bleeding. 7. 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. 8. The appropriate antiplatelet and anticoagulation therapy should be administered pre‐ and post‐procedure as suggested in Section 9.1 of these instructions. 9. In the event of complications such as infection, pseudoaneurysm or fistulization, surgical removal of the stent ...
Page 7 • Patients with lesions of the ostium of the common carotid. • Patients with highly calcified lesions resistant to PTA. • Concurrent treatment of bilateral lesions. Patient Characteristics: • Patients at low‐to‐moderate risk for adverse events from carotid endarterectomy. • Patients experiencing acute ischemic neurologic stroke or who experienced a stroke within 48 hours. • Patient has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure. • Patients with ipsilateral intracranial or extracranial arterial stenosis greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or intracranial tumor. • Patients with arterio‐venous malformations in the territory of the target carotid artery. • Patients with diathesis or coagulopathies. • Patients with poor renal function, who, in the physician’s opinion, may be at high risk for a reaction to contrast medium. • Patients with perforated vessels evidenced by extravasation of contrast media. • Patients with aneurismal dilation immediately proximal or distal to the lesion. • Pregnant patients or patients under the age of 18. Access Characteristics: • Patients with known internal carotid artery tortuosity that would preclude the use of catheter‐based techniques. • Patients with known common carotid or internal carotid artery tortuosity that would preclude the use of catheter‐based techniques. • Patients in whom common carotid access is not possible. 2. Risk of distal embolization may be higher if the ENROUTE Transcarotid Stent System cannot be used in conjunction with the ENROUTE Transcarotid NPS during the carotid stenting procedure. 5.3 Device Use Warnings 1. USE OF A SMALLER THAN INDICATED ACCESSORY DEVICE OTHER THAN THE ENROUTE TRANSCAROTID ARTERIAL SHEATH MAY LEAD TO INTRODUCTION OF AIR INTO THAT DEVICE AS THE STENT DELIVERY SYSTEM IS ADVANCED, WHICH MAY NOT BE REMOVED DURING AIR ASPIRATION. 2. Ensure that the catheter system is flushed according to the steps outlined in "Introduction of Stent Delivery System" (Section 9.4). Failure to do so could result in air entering the ENROUTE’s Transcarotid Arterial Sheath. 3. Ensure that there is a tight seal between the ENROUTE catheter and the valve for the ENROUTE Transcarotid Arterial Sheath during aspiration. Failure to do so could result in air entering the ENROUTE Transcarotid Arterial Sheath. 4. The black dotted pattern on the gray temperature exposure indicator found on the pouch must be clearly visible. DO NOT USE THE PRODUCT IF THE ENTIRE TEMPERATURE EXPOSURE INDICATOR IS COMPLETELY BLACK as the ...
Page 8 10. The stent is not designed for dragging or repositioning. 11. Once the stent is partially deployed, it cannot be recaptured using the stent delivery system. 12. As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm or rupture. 13. When multiple stents are used, they should be of similar composition. 14. Long‐term outcomes following repeat dilatation of endothelialized stents are unknown. 6.0 Precautions 6.1 Stent Handling Precautions 1. The ENROUTE Transcarotid Stent System is supplied STERILE and is intended for single use only. DO NOT resterilize and/or reuse the device. 2. The ENROUTE Transcarotid Stent System is shipped with the Tuohy Borst valve in the OPEN position. Care should be taken not to pre‐deploy the stent. The device should be prepped in the tray. (See Section 9.3 of these instructions). 3. Do not use the ENROUTE Transcarotid Stent System after the "Use By" date specified on the package. 4. Do not use if the pouch is opened or damaged. 5. Store in a cool, dark, dry place. 6.2 Stent Placement Precautions 1. Venous access should be available during carotid stenting in order to manage bradycardia and/or hypotension either by pharmaceutical intervention or placement of a temporary pacemaker, if needed. 2. When catheters are in the body, they should be manipulated only under fluoroscopy. Radiographic equipment that provides high quality images is needed. 3. The delivery system is not designed for the use of power injection. Use of power injection may adversely affect device performance. 4. If resistance is met during delivery system introduction, the system should be withdrawn and another system used. 5. Prior to stent deployment, remove all slack from the catheter delivery system (see Section 9.4, 4 of these instructions). 6. Adequate distance must be maintained from the distal tip of the transcarotid access sheath and the proximal edge of the stent to avoid stent delivery within the lumen of the sheath. 7. When treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the proximal lesion. Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the chance for dislodging stents that have already been placed. 8. Overlap of sequential stents is necessary, but the amount of overlap should be kept to a minimum (approximately 5 mm). In no instance should more than 2 stents overlap. 9. Fractures of this stent may occur. Fractures may also occur with the use of multiple overlapping stents. Fractures have been reported most often in clinical uses for which the safety and effectiveness have not been established. The causes and clinical implications of stent fractures are not well characterized. Care should also be ...
Page 9 6.4 MRI Safety Information 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. 7.0 Adverse Events The ENROUTE Transcarotid Stent System is a stenting platform based upon the FDA‐approved Cordis PRECISE Nitinol Stent System (PRECISE). The ENROUTE Transcarotid Stent System is identical to the PRECISE Stent System with the exception of the working length of the delivery system. The ENROUTE Transcarotid Stent System has a working length of 57 cm whereas the PRECISE Stent System has a working length of 135 cm. The adverse event information presented herein encompasses clinical trial data on the use of the PRECISE Stent System in combination with the ENROUTE Transcarotid NPS (see Section 7.1, Observed Adverse Events). Additional adverse event information is derived from clinical trial data on the use of the PRECISE Stent System and the ANGIOGUARD® XP Emboli Capture Guidewire. 7.1 Observed Adverse Events – Clinical Studies Carotid stenting with reverse flow proximal embolic protection using the PRECISE Stent System and the ENROUTE Transcarotid Neuroprotection System was conducted in 65 patients in the ROADSTER study (n=52) and the PROOF study (n=13). In the ROADSTER study, a sub‐study of 52 patients who were at high risk for complications from carotid endarterectomy (CEA) were enrolled to evaluate the safety and effectiveness of the PRECISE Stent System when used with the ENROUTE Transcarotid Neuroprotection System. In the PROOF Study, 13 patients who were at standard and high risk for complications from CEA were enrolled to evaluate the feasibility of the carotid angioplasty and stenting with ENROUTE Transcarotid NPS. These data serve as the basis for the safety and effectiveness of the ENROUTE Transcarotid Stent System which differs from the PRECISE Stent System only in the working length of the delivery system. Safety and effectiveness data for the PRECISE Stent System when used with the ANGIOGUARD XP Emboli Capture Guidewire can be found on FDA’s website at the following URL: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030047b.pdf. 510(k) clearance of the ENROUTE Transcarotid NPS was supported by data from the full cohort of patients enrolled in the ROADSTER study (n=141) when used with any FDA‐approved carotid stent system. The Major Adverse Event rate in the ROADSTER sub‐study population (subjects treated with a combination of the PRECISE Stent and the ENROUTE Transcarotid NPS) was 1.9%. One subject experienced a minor ipsilateral stroke ...
Page 10 7.2 ROADSTER Study – Sub‐Study of Patients Treated with a Combination of the PRECISE Stent System and the ENROUTE Transcarotid Neuroprotection System This prospective, single arm, multi‐center study included 52 patients at high risk for complications from CEA. The PRECISE Stent System was used as a surrogate for the ENROUTE Transcarotid Stent System as the two systems differ only in the working length. The major adverse event (MAE) rate was defined as death, stroke, or MI to 30 days. The 30‐day MAE rate for these patients was 1.9%. Serious adverse events to 30 days from the ROADSTER sub‐study are presented in the following table: Table 2 Serious Adverse Events to 30 Days All PRECISE Stent Subjects in System Organ Class ROADSTER Preferred Term (N=52) Number (%) of Subjects with one or more Serious Adverse Events 7 (13.5%) Blood And Lymphatic System Disorders 1 (1.9%) Anaemia 1 (1.9%) Cardiac Disorders 1 (1.9%) Cardiac Failure Congestive 1 (1.9%) Injury, Poisoning And Procedural Complications 1 (1.9%) Post Procedural Haemorrhage 1 (1.9%) Nervous System Disorders 1 (1.9%) Cerebrovascular Accident 1 (1.9%) Respiratory, Thoracic And Mediastinal Disorders 1 (1.9%) Atelectasis 1 (1.9%) Vascular Disorders 2 (3.8%) Artery Dissection 1 (1.9%) ...
Page 11 Table 3 ENROUTE Transcarotid Stent System Serious Adverse Events System Organ Class All PRECISE Stent Subjects in PROOF (N=13) Number (%) of Subjects with one or more Serious Adverse Events 13 (100%) Cardiac Disorders 2 (15.4%) Gastrointestinal Disorders 2 (15.4%) General Disorders and Administration Site Conditions 1 (7.7%) Infections and Infestations 1 (7.7%) Investigations 2 (15.4%) Nervous System Disorders 7 (53.8%) Respiratory, Thoracic, and Mediastinal Disorders 1 (7.7%) Skin and Subcutaneous Tissue Disorders 2 (15.4%) Surgical and Medical Procedures 1 (7.7%) Vascular Disorders 7 (53.8%) 7.4 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): ...
Page 12 • Hemorrhage • Hyperperfusion syndrome • Hypotension/hypertension • Hypomagnesaemia • Hypophoshatemia • 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 ...
Page 13 (ITT) subjects at high risk for complications from CEA were enrolled between November 2012 and July 2014. A sub‐ study of 18 lead‐in and 34 pivotal subjects at high risk for complications from CEA and treated with the PRECISE Stent System was also conducted. The study included patients with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography. The study population consisted of male and female subjects at least 18 years of age meeting one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be >50% as determined by angiogram and the patient has a history of stroke (minor or non‐disabling), TIA and/or amaurosis fugax within 180 days of the procedure, OR Asymptomatic: Stenosis must be >70% as determined by angiogram without any neurological symptoms within the prior 180 days. Eligible subjects were scheduled to undergo carotid revascularization any FDA‐approved carotid artery stent system with the ENROUTE Transcarotid NPS. Subjects were followed for 30 days post‐procedure. Patients met at least one of the surgical high‐risk criteria listed below. Anatomic High Risk Inclusion Criteria: Contralateral carotid artery occlusion Tandem stenoses >70% High cervical carotid artery stenosis Restenosis after carotid endarterectomy Bilateral carotid artery stenosis requiring treatment (Treatment of the contralateral vessel must be scheduled at least 30 days post index procedure). Hostile Necks which the Investigator deems safe for transcarotid access including: I. Prior neck irradiation II. Radical neck dissection III. Cervical spine immobility Clinical High Risk Inclusion Criteria: G. Patient is  75 years of age H. Patient has > 2‐vessel coronary artery disease and history of angina Patient has a history of angina  Canadian Cardiovascular Society (CCS) angina class 3 or 4 or ...
Page 14  Major Adverse Events (stroke, death and myocardial infarction)  Adverse Events  Access Site Complications Compulsory clinical follow‐up included neurological examinations (NIH Stroke Scale, Barthel ADL Index, Modified Rankin Scale, and Cranial Nerve Palsy assessment), duplex ultrasound, and laboratory assessments of cardiac enzymes and 12‐lead EKG. Subjects who were suspected of having a stroke were asked to return at 3 months post‐ procedure for a follow‐up neurological exam. Subjects suspected of having a procedure related cranial nerve injury were asked to return at 6 months post‐procedure for a follow up neurological examination. Patient follow‐up and accountability are presented in the following table for the sub‐study population: Table 4 Patient Follow‐Up and Accountability 30‐Day Follow‐Up 90‐Day Follow‐Up 6‐Month Follow‐Up N % % 52/52 100% 100% N/A Patient demographics in the sub‐study population are presented in the following table: Table 5 Patient Demographics in the Sub‐Study Population Observation All PRECISE Stent Patients in ROADSTER (N=52) Age (Years) 73.0 ± 9.07 Symptomatic ...
Page 15 Bilateral Stenosis Requiring Treatment 32.7% Hostile Neck 15.4% >2 Vessel Coronary Disease 7.7% Chronic Renal Insufficiency 1.9% The primary effectiveness outcomes include acute device success, technical success, and procedural success. In the sub‐study population, acute device success was defined as the ability to insert the device, establish flow reversal, and remove the device was 100%. Technical success defined as acute device success plus the ability to deliver interventional tools was 100% in the sub‐study population. Procedural success defined as technical success in the absence of a Major Adverse Event (S/D/MI) was 98.1% in the sub‐study population. Table 6: ROADSTER Sub‐study ‐ Summary of Baseline Vessel and Lesion Characteristics All PRECISE Stent Subjects Observation (n=52) Target Lesion Location Left 27 (51.9%) Right 25 (48.1%) Vessel to be Treated ICA 37 (71.2%) ICA + CCA 15 (28.8%) Distance between clavicle and bifurcation (cm) N Mean 6.6 Standard Deviation 1.21 Median 6.5 Minimum, Maximum 5, 10 95% Confidence Interval (6.3, 6.9) ...
Page 16 All PRECISE Stent Subjects Observation (n=52) Standard Deviation 8.05 Median 17.6 Minimum, Maximum 5, 39 95% Confidence Interval (16.4, 20.9) Pre‐Procedure Percent Stenosis (%) N Mean 86.1 Standard Deviation 9.01 Median 90.0 Minimum, Maximum 60, 99 95% Confidence Interval (83.6, 88.6) Table 7 Acute Device, Technical and Procedural Success in Subjects Treated with the PRECISE Stent All PRECISE Stent Subjects Observations (N=52) Acute Device Success 52 (100%) Technical Success 52 (100%) Procedural Success 51 (98.1%) The Major Adverse Event rate in the sub‐study population (subjects treated with a combination of the PRECISE Stent System and the ENROUTE Transcarotid NPS, N=52) was 1.9%. One sub‐study subject experienced a minor ipsilateral stroke within the 30‐day follow‐up period. The following table presents the Major Adverse Event rate in ...
Page 17 Observations All PRECISE Stent Patients in ROADSTER (at 30 days) (N=52) Limited Surgical Wound 0 (0.0%) Hematoma Surgical Wound Hematoma 0 (0.0%) Arterial Access Site Hematoma 0 (0.0%) Femoral Vein Access Site 0 (0.0%) Hematoma Re‐bleeding 1 (1.9%) Contrast Usage (cc) Mean 66.1 Standard Deviation 42.14 Median 55.0 Minimum, Maximum 12, 220 Table 9: Summary of All Adverse Events (Sub‐study Subjects) System Organ Class All PRECISE Stent Subjects Preferred Term (N=52) Number (%) of Subjects with one or more Adverse Events 21 (40.4%) Blood And Lymphatic System Disorders 2 (3.8%) Anaemia 2 (3.8%) Cardiac Disorders 1 (1.9%) Atrial Fibrillation ...
Page 18 Respiratory, Thoracic And Mediastinal Disorders 3 (5.8%) Atelectasis 1 (1.9%) Rales 1 (1.9%) Rhinorrhoea 1 (1.9%) Wheezing 1 (1.9%) Vascular Disorders 8 (15.4%) Artery Dissection 1 (1.9%) Hypotension 6 (11.5%) Orthostatic Hypotension 1 (1.9%) The patient demographics and results from the ROADSTER sub‐study including subjects receiving the PRECISE stent (N=52) were comparable those of the ROADSTER pivotal study cohort (N=141). 9.0 Directions for Use 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. 9.1 Peri‐Procedural Care Table 10 Pre‐Procedure Medications Medication Dose Time prior to Notes procedure Aspirin 75‐325 mg* At least 72 hrs A 650 mg loading dose of aspirin, provided that it is not enteric coated or extended release, at least 4 hours prior ...
Page 19 Table 11 Post‐Procedure Medications Medication Dose Duration post‐ Notes procedure Aspirin 75‐325 mg* Daily, Aspirin dosage may be adjusted at the discretion of the continued Investigator and/or if warranted by the patient's medical indefinitely condition, i.e., documented intolerance, GI bleed, etc. All change in medications are to be documented on the Concomitant Medication CRF. Clopidogrel 75 mg Daily, Clopidogrel dosing may extend at physician's discretion. for minimum of 4 The physician may substitute prasugrel, ticlopidine, or a weeks generic version of clopidogrel per the manufacturer's published guidelines. *As stated in the "2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary." and "ESVS Guidelines. Invasive Treatment for Carotid Stenosis: Indications, Techniques." In addition to the usual care and the suggested peri‐procedure pharmacological regimen, special attention to diagnosis and management of the following conditions are critical for optimal patient care: • Bradycardia or tachycardia • Hypertension or hypotension • Acute and subacute stent thrombosis • Hyperfusion syndrome 9.2 Pre‐Procedure Refer to Section 9.1 of these instructions for the suggested pre‐procedure pharmacological treatment regimen. The placement of the stent in a stenotic or obstructed carotid artery should be done in a procedure room ...
Page 20 Table 12 ENROUTE Transcarotid Stent System ‐ Stent Size Selection Table Vessel Unconstrained % Length Lumen Stent Foreshortening* Diameter Diameter (%) (mm) (mm) 3.0 – 4.0 4.0 – 5.0 5.0 – 6.0 6.0 – 7.0 7.0 – 8.0 8.0 – 9.0 10.0 *Calculated 2. Preparation of Stent Delivery System CAUTION: The ENROUTE Transcarotid Stent System is supplied STERILE and is intended for single use only. DO NOT resterilize and/or reuse the device. Assure that the device had been properly stored in a cool, dark, dry place prior to use. CAUTION: Use the ENROUTE Transcarotid Stent System prior to the “Use By” date specified on the package. Do not use if the pouch is opened or damaged. CAUTION: The ENROUTE Transcarotid Stent System is shipped with the Tuohy Borst valve OPEN. Be careful not to prematurely deploy the stent during preparation. The system should be prepped in the sterile tray per the below instructions. Close the Tuohy Borst valve prior to removing the device from the tray. a. Open the outer box to reveal the pouch containing the stent and delivery system. b. Check the temperature exposure indicator on the pouch to confirm that the black dotted pattern with a gray background is clearly visible. Do not use if entire temperature exposure indicator is completely black as the unconstrained stent diameter may have been compromised. c. After careful inspection of the pouch looking for damage to the sterile barrier, carefully peel the pouch open and remove the tray. Without removing the device from the tray, examine the device for any damage. If it is suspected that the sterility or performance of the device has been compromised, the device should not be used. ...
Page 21 WARNING: Do not use with Ethiodol or Lipiodol * contrast media, which may adversely affect the stent delivery system. *Ethiodol and Lipiodol are Trademarks of Gerbert S.A. WARNING: Do not expose the delivery system to organic solvents (e.g., alcohol), as structural integrity and/or function of the device may be impaired. CAUTION: The delivery system is not designed for the use of power injection. Use of power injection may adversely affect device performance. 1. Insertion of ENROUTE Transcarotid Neuroprotection System a. Access the treatment site utilizing the ENROUTE Transcarotid NPS in accordance with the Instructions for Use. b. The ENROUTE Transcarotid Stent System is compatible with a .014" (0.36 mm) or smaller guidewire. 2. Dilation of Lesion a. If appropriate, pre‐dilate the lesion using standard PTA techniques. b. Remove the PTA balloon catheter from the patient maintaining lesion access with the guidewire. 3. Introduction of Stent Delivery System ...
Page 22 Fig. 2 ENROUTE Transcarotid Stent System Description (Refer to Fig. 1 for component list) a. Flush the guidewire lumen of the stent delivery system with heparinized saline by connecting a 5‐cc syringe filled with heparinized saline solution to the stopcock attached to the Y connection (9) on the Tuohy Borst valve (1) to expel air. Ensure that the Tuohy Borst proximal end valve (12) is in the locked position to prevent premature stent deployment. Apply positive pressure to the syringe until saline weeps from the guidewire exit port (16). While covering the guidewire exit port (16) with thumb and forefinger, apply positive pressure to the syringe until saline weeps from the catheter tip (4) and the space between the outer sheath radiopaque marker (11) and the catheter tip (4). Continue to flush to ensure all air is removed from the system, then close the stopcock attached to the Y connection (9) on the Tuohy Borst valve. b. Ensure the Tuohy Borst valve (1) connecting the inner shaft and outer sheath is locked by rotating the proximal valve end (12) in a clockwise direction to prevent premature stent deployment. c. Advance the ENROUTE Transcarotid Stent System over the .014" (0.36 mm) guidewire until the guidewire exit port (16) is just outside the ENROUTE Transcarotid Arterial Sheath valve. Look for and confirm back flow through the guidewire exit port (16) opening. d. After confirming back flow, advance the ENROUTE Transcarotid Stent System to the lesion site. e. Perform contrast injections in accordance to ENROUTE Transcarotid NPS Instructions for Use. CAUTION: If resistance is met during delivery system introduction, the system should be withdrawn and another system should be used, while the ENROUTE Transcarotid NPS remains in place. 4. Slack Removal a. Advance the stent delivery system past the lesion site. b. Pull back the stent delivery system until the radiopaque inner shaft markers (leading and trailing ends) move in position so that they are proximal and distal to the target lesion. c. Ensure the stent delivery system outside the patient remains flat and straight. CAUTION: Prior to stent deployment, remove all slack from the catheter delivery system. Slack in the catheter shaft either outside or inside the patient may result in deployment of the stent beyond the lesion site. 5. Stent Deployment WARNING: The stent is not designed for dragging or repositioning. Once the stent is partially deployed, it cannot be recaptured using the stent delivery system. The mechanism for stent deployment is outer sheath retraction. ...
Page 23 Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand. NOTE: It is recommended that heparin (intravenous) be given during the procedure before the ENROUTE Transcarotid NPS is placed. The initial bolus doses of heparin should be approximately 3,000 to 5,000 units (with necessary weight adjustments). Additional bolus doses of heparin should be given to maintain an ACT near 250 seconds during the entire procedure. No heparin should be given after the procedure until hemostasis at the puncture site is achieved. a. Verify that the delivery system’s radiopaque inner shaft markers (leading and trailing ends) are proximal and distal to the target lesion. b. Verify that the delivery system's radiopaque inner shaft marker (trailing end) is distal to the radiopaque marker at the tip of the ENROUTE Transcarotid Arterial Sheath. c. Unlock the Tuohy Borst proximal valve end connecting the inner shaft and outer sheath of the delivery system. d. Ensure that the ENROUTE Transcarotid Arterial Sheath does not move during deployment. e. Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position. Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker. CAUTION: When more than one stent is required to cover the lesion, or if there are multiple lesions, the more distal stent should be placed first. Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the chance for dislodging stents that have already been placed. CAUTION: Overlap of sequential stents is necessary but the amount of overlap should be kept to a minimum (approximately 5 mm). In no instance, should more than two (2) stents ever overlap. 6. Post‐Deployment Stent Dilatation WARNING: Long‐term outcomes following repeat dilatation of endothelialized stents are unknown. CAUTION: The delivery system is not designed for the use of power injection. Use of power injection may adversely affect device performance. CAUTION: Re‐crossing a deployed stent with adjunct devices must be performed with caution. a. While using fluoroscopy, withdraw the entire delivery system as one unit, over the guidewire and out of the body. Remove the delivery device from the guidewire. NOTE: If any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit. (Do not remove guidewire.) b. Using fluoroscopy, visualize the stent to verify full deployment. c. If incomplete expansion exists within the stent at any point along the lesion, post‐deployment balloon dilatation (standard PTA technique) can be performed. d. Select an appropriate size PTA balloon dilatation catheter and dilate the lesion with conventional technique. The inflation diameter of the PTA balloon dilatation catheter used for post‐dilatation should not exceed the diameter of the reference vessel. e. Remove the PTA balloon from the patient. 7. Post Stent Placement a. A post‐stent angiogram can be obtained per institutional protocol. b. Remove the ENROUTE Transcarotid NPS in accordance with that device’s Instructions for Use. ...
Page 24 8. Patient Information In addition to these Instructions for Use, the ENROUTE Transcarotid Stent System is packaged with a Stent Implant Card for the patient that contains specific information about the ENROUTE Transcarotid Stent System. All patients should be instructed to keep this card in their possession at all times for procedure/stent identification. 9. How Supplied ENROUTE Transcarotid Stent System is supplied sterile by ethylene oxide gas and is intended for SINGLE USE ONLY. It has not been validated for resterilization or reuse. Silk Road Medical shall not be responsible for any damages, including without limitation direct, incidental or consequential damages, resulting from reuse or resterilization of this product. 10.0 DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY SILK ROAD MEDICAL, INC. PROVIDES NO EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY FOR ANY OF ITS PRODUCTS, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. UNDER NO CIRCUMSTANCES SHALL SILK ROAD MEDICAL BE LIABLE FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC LAW. NO PERSON HAS THE AUTHORITY TO BIND SILK ROAD MEDICAL TO ANY REPRESENTATION OR WARRANTY TO THE CONTRARY, EXCEPT AS SPECIFICALLY SET FORTH HEREIN. Descriptions or specifications in Silk Road Medical printed matter, including this IFU (Instructions for Use), are meant solely to generally describe the product(s) at the time of manufacture and do not constitute any express or implied representation or warranty for any product, including without limitation any implied warranty or merchantability or fitness for a particular purpose. All Silk Road Medical products are intended for single use only. None is to be reused or resterilized for any purpose and none has been validated for multiple uses. Silk Road Medical shall not be responsible for any damages, including without limitation direct, incidental, or consequential damages resulting from reuse or resterilization of its products. 11.0 LICENSE AND PATENT DISCLOSURE This product is being made, sold and distributed pursuant to a license from Cordis Corporation. Phone: +1 (408) 720‐9002 Fax: +1 (408) 720‐9013 www.silkroadmed.com ©Silk Road Medical, Inc. 2015 July 2015 11752.C ENROUTE and the Silk Road Medical logo are trademarks of Silk Road Medical. Information concerning patents and trademarks for Silk Road products and procedures can be found at www.silkroadmed.com/patents. ...