Product Information: Wingspan® Stent System with Gateway® PTA Balloon Catheter*

Wingspan® Stent System with Gateway® PTA Balloon Catheter* is manufactured by Boston Scientific for Stryker Neurovascular.

Overview

This section includes summaries and PowerPoint Presentations related to studies on ICAD treatment.

Stryker has attempted to provide useful materials about studies that reflect, in a fair and balanced way, the relevant data on the product and disease state.

Wingspan Stent System HDE Study

Study: A Novel, Self-Expanding, Nitinol Stent in Medically Refractory Intracranial Atherosclerotic Stenosis – The Wingspan Study
Clinical Data Summary: Download PDF
PPT Presentation: Download PPT

Wingspan Stent System US Multicenter Registry: Periprocedural Results

Study: US Multi-Center Experience with the Wingspan® Stent System for the Treatment of Intracranial Atheromatous Disease – Periprocedural Results
Clinical Data Summary: Download PDF
PPT Presentation: Download PPT

Wingspan Stent System US Multicenter Registry: Subset Analysis

Study: Influence of Patient Age and Stenosis Location on Wingspan In-Stent Restenosis
Clinical Data Summary: Download PDF
PPT Presentation: Download PPT

Wingspan Stent System NIH Registry: 70-99 percent Stenosis Analysis

Study: The NIH Registry of the Wingspan® Stent System Use for Symptomatic 70-99 percent Intracranial Arterial Stenosis
Clinical Data Summary: Download PDF
PPT Presentation: Download PPT

Wingspan Stent System US Multicenter Registry: Long Term 14.2 Month Results

Study: US Multi-Center Wingspan® Stent System Registry for Symptomatic Intracranial Atherosclerotic Disease: 1 Year Results
Clinical Data Summary: Download PDF
PPT Presentation: Download PPT

Other Treatment Options: SSYLVIA Study

Study: Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA) Study Results
Clinical Data Summary: Download PDF
PPT Presentation: Download PPT

Cerebrovascular Complications Risk Factor Analysis

Study: Risk Factors Associated with Major Cerebrovascular Complications After Intracranial Stenting
Clinical Data Summary: Download PDF
PPT Presentation: Download PPT

WASID Secondary Analysis on Predictors of Stroke

Study: Predictors of Ischemic Stroke in the Territory of a Symptomatic Intracranial Arterial Stenosis
Clinical Data Summary: Download PDF
PPT Presentation: Download PPT

Disclaimer *Humanitarian Device. The Wingspan® Stent System with Gateway® PTA Balloon Catheter is authorized by Federal Law for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≤ 50 percent stenosis that are accessible to the system. The effectiveness of this device for this use has not been demonstrated. The Gateway PTA Balloon Catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries prior to stenting for the purpose of improving intracranial perfusion. IRB Review Required.

Wingspan® Stent System Prescriptive Information

See package insert for complete indications, contraindications, warnings and instructions for use.

Humanitarian Device: The Wingspan® Stent System with Gateway® PTA Balloon Catheter is authorized by Federal law for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with >50% stenosis that are accessible to the system. The effectiveness of this device for this use has not been demonstrated.

Indications for Use

The Wingspan Stent System with Gateway PTA Balloon Catheter is indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with >50% stenosis that are accessible to the system.

Contraindications

• Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
• Lesions that are highly calcified or otherwise could prevent access or appropriate expansion of the Stent.

Adverse Events

Observed Adverse Events:
Infection; TIA; Stroke; Hematoma; Vasospasm; Hemorrhagic Event; Hypertension; Peripheral vascular diseases; Neurological symptoms; Pain; AMI; Angina; Arrhythmia; Creatinine increase; Hematuria; Hypoglycemia/hyperglycemia; Asymptomatic Thromboembolic Event; Bradycardia (35 min); Broken middle-foot left/V-fracture; Chronical antrum gastritis; Death; Elevated bilirubin, GOT, GPT; Fever; Hiatus hernia; Hypervolemia; New distal in stent stenosis; Pulmonary edema; Respiratory failure; Seizure; Syncope.

Potential Adverse Events:
Aneurysm; Cerebral ischemia; Coagulopathy; Drug reaction to contrast or antiplatelet medication; Emboli (air, tissue, or thrombotic tissue); Hypotension; Intimal dissection; Ischemia/infarct; Pseudoaneurysm; Restenosis; Stent migration; Stent misplacement; Stent occlusion; Stent embolization; Stent thrombosis; Thromboembolic event; Vessel dissection; Vessel occlusion; Vessel perforation; Vessel rupture; Vessel spasm; Vessel thrombosis; Vessel trauma requiring repair or surgical intervention.

Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Warnings

• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
• For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure that, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of a patient.
• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
• The Wingspan® Stent System with Gateway® PTA Balloon Catheter should only be used by physicians who have received appropriate training in interventional neuroradiology and treatment of intracranial atherosclerotic disease.
• The Wingspan Stent System is not designed or intended for contrast injections or injections other than heparinized saline.
• If excessive resistance is encountered during the use of the Wingspan Stent System or with the Gateway PTA Balloon Catheter at any time during the procedure, discontinue use of the System. Movement of the System against resistance may result in damage to the vessel, or a System component.
• In animal evaluations, the severity of vessel stenosis/neointimal thickness appears to be correlated with the degree of trauma inflicted on the arterial walls by Stent placement or Stent radial expansion.
• Experience with stent implants indicates that there is a risk of restenosis. Subsequent restenosis may require repeat dilation of the vessel segment containing the stent. The risks and long-term outcome following repeat dilation of endothelialized stents is unknown at present.
• If the stent is implanted adjacent to or contacting other implanted metal, such as another stent or embolic coil, the metals should be of similar composition to avoid galvanic corrosion potential.

Precautions / Cautions

• Federal Law (USA) restricts this device to sale by or on the order of a physician.
• The Wingspan Stent System and the Gateway PTA Balloon Catheter are provided STERILE for single use only. Store in a cool, dry place.
• Use the Wingspan Stent System and Gateway PTA Balloon Catheter prior to the “Use By” date printed on the package.
• Select a Stent size (length and diameter) that extends a minimum of 3mm on both sides of the lesion.
• Carefully inspect the sterile package and Wingspan Stent System prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components.
• Typical antiplatelet and anticoagulation regimen used for interventional intracranial procedures is an important adjunct to Stent treatment. Patients must be advised to take their prescribed medications after the Stent is implanted and should be counseled on the risk of not complying with medical therapy. In-stent thrombosis may occur during the procedure if proper antiplatelet and anticoagulation therapy is not administered.
• Do not steam shape the tip of the Wingspan Stent System because it could damage the Stent or Delivery System.
• Implanting a Stent may lead to dissection of the vessel distal or proximal to the Stent and may cause other complications (vasospasm/acute closure) of the vessel requiring additional intervention (i.e., further dilation, placement of stents).
• Do not deploy the Stent if it is not properly positioned in the vessel.
• Placement of the Stent may compromise side branch patency.
• Follow the Wingspan Stent System preparation and use instructions carefully.Previous studies have shown that some metal stents may be incompatible with MRI scanning. The Wingspan Stent System has been shown to be MRI compatible in MRI systems operating at field strengths of 3.0 Tesla or lower. MRI laboratory evaluation demonstrated that no significant image distortion or heating was created by the presence of the Stents at scanning sequences commonly used during MRI procedures.
• Do not use the Wingspan Stent System or the Gateway PTA Balloon Catheter for repositioning or recapturing the Stent.
• Exercise caution when crossing the deployed Stent with guidewires or other devices.
• In tortuous vessels, a stiff guidewire may cause binding within the Wingspan Stent System or the Gateway Balloon Catheter during deployment. In such cases, use only soft guidewires, and position the floppy section of the guidewire within the Stent.
• After deployment, the Stent may foreshorten up to 2.4% in 2.5mm Stents and up to 7.1% in 4.5mm Stents.
• Stent retrieval methods (use of additional wires, snares and/or forceps) may result in additional trauma to the vasculature and/or the vascular access site. Complications may include bleeding, hematoma, or pseudoaneurysm.

Gateway PTA Balloon Catheter Prescriptive Information

See package insert for complete indications, contraindications, warnings and instructions for use.

Humanitarian Device: The Wingspan® Stent System with Gateway® PTA Balloon Catheter is Authorized by Federal law for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with >50% stenosis that are accessible to the system. The effectiveness of this device for this use has not been demonstrated.

Indications for Use

The Gateway PTA Balloon Catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries prior to stenting for the purpose of improving intracranial perfusion.

Contraindications

The Gateway PTA balloon catheter is contraindicated for use in:

• Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
• Patients who are judged to have a lesion which prevents effective angioplasty.

Potential Adverse Effects

Adverse events (in alphabetical order) may be associated with the use of intracranial angioplasty in stenotic lesions of the intracranial arteries: Aneurysm; Cerebral ischemia; Coagulopathy; Death; Drug reactions to contrast or antiplatelet medication; Emboli (air, tissue or thrombotic emboli); Hematoma, pain, or infection at access site; Hemorrhage; Hypotension/Hypertension; Hypervolemia; Infection; Ischemia/Infarct; Neurological symptoms; Pain, Pseudoaneurysm; Restenosis; Seizure; Stroke; Syncope; Thromboembolic event; Transient ischemic attack (TIA); Vasospasm; Vessel dissection; Vessel occlusion; Vessel perforation; Vessel rupture; Vessel thrombosis; Vessel trauma requiring surgical repair or intervention Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Warnings

• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
• For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure that, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of a patient.
• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
• Since the use of this device carries the associated risk of subacute thrombosis, vascular complication and/or bleeding events, judicious selection of patients is necessary.
• Only physicians who have received the appropriate training should perform intracranial angioplasty.
• Angioplasty and stenting procedures should only be performed at hospitals where emergency intracranial surgery can be readily performed in the event of a potentially injurious or life-threatening complication.

Precautions / Cautions

• Federal Law (USA) restricts this device to sale by or on the order of a physician.
• Store in a cool, dry, dark place.
• Note product “Use By” date.
• Follow the Gateway PTA Balloon Catheter preparation and use instructions carefully.
• Do not prepare or pre-inflate the balloon other than as directed. Use the balloon purging technique described in the Instructions for Use.
• Typical antiplatelet and anticoagulation regimen used for interventional intracranial procedure is an important adjunct to balloon angioplasty treatment. Do not use the Gateway PTA Balloon Catheter in patients in whom antiplatelet and/or anticoagulation therapy is contraindicated. Vessel thrombosis may occur during the procedure if proper antiplatelet and anticoagulation therapy is not administered.
• If difficulty is experienced during inflation, do not continue; remove the device and do not attempt to use it. Select another device.
• Angioplasty may lead to dissection of the vessel and may cause other complications (vasospasm/acute closure) of the vessel requiring additional intervention (i.e., further dilation, placement of stents).
• Use only the appropriate balloon inflation media. Do not use air or any gaseous medium to inflate the balloon because it may cause uneven inflation and complications.
• To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the lesser of the vessel diameters just proximal and distal to the stenosis.
• Do not use a guidewire having a diameter greater than 0.014in (0.36mm).
• When the delivery catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. If resistance is met during manipulation, determine the cause of the resistance before proceeding.
• Infusion of any medium other than a flush of heparinized normal saline through the guidewire lumen may compromise device performance.
• Do not attempt to reposition a partially deployed balloon. Attempted repositioning of a partially deployed balloon may result in severe vessel damage.
• Balloon pressures should be monitored during inflation. Do not exceed rated burst pressure indicated on the product label. Use of pressures higher than those specified on the product label may result in a ruptured balloon and potential intimal damage and dissection. The rated burst pressure is based on the results of in vitro testing. At least 99.9% of the balloons (with a 95% confidence interval) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization.
• Before withdrawing the device, visually confirm complete balloon deflation by fluoroscopy. If the balloon has already been inflated and difficulty is experienced deflating (a non-deflate), connect a large-barrel syringe and manually attempt to deflate the device.
• In order to achieve optimal performance of Gateway PTA Balloon Catheters and Boston Scientific steerable guidewires and to maintain the lubricity of the BIOSLIDE® Coating, it is critical that a continuous flow of appropriate flush solution be maintained between a) the Gateway PTA Balloon Catheter and guide catheter, and b) the Gateway PTA Balloon Catheter and any intraluminal device. In addition, flushing aids in preventing contrast crystal formation and/or clotting on both the guidewire and inside the catheter lumen.
• The recommended continuous flush set up requires two stopcocks and two rotating hemostatic valves (RHV); the RHV’s provide a fluid tight seal and are attached to the guide catheter and Gateway PTA Balloon Catheter. The stopcocks attach to the RHV sidearms, which become infusion ports for appropriate flush or contrast medium injection.