Humanitarian Use Devices
Patients with angiographically documented wide-neck, intracranial, saccular or fusiform aneurysms who are deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization. There are no age or gender restrictions. A brain aneurysm is a weakening in the wall of an artery in the brain, causing the affected area to stretch out like a balloon. Intracranial aneurysms are classified as saccular and nonsaccular, according to their shape and etiology.
A wide-neck aneurysm is one that has a wide opening where the aneurysm arises from the artery. Wide-neck aneurysms have a neck width greater than or equal to 4mm or a dome-to-neck ratio of less than 2mm. These types of aneurysms occur in about 25% of persons with brain aneurysms. Wide-neck aneurysms are difficult to treat both surgically and endovascular.
The Codman Enterprise 2 is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of ≥2.5 mm and ≤4 mm. Wide-neck is defined as having a neck width >4 mm or a dome-to-neck ratio.
Device Description
The Codman Enterprise 2 is comprised of a self-expanding stent (VRD) and a delivery system. The delivery system is comprised of a delivery wire and an introducer. The stent is pre-loaded on the delivery wire inside the introducer. The implantable stent is made of Nitinol and has a closed cell design. The stent has 4 markers on each end, and is coated with a polymer. The delivery wire is composed of a Nitinol core-wire with radiopaque markers. The introducer consists of a polymer tube with a tapered distal end. It is designed to protect the stent from damage and creates an uninterrupted passage for the stent to be transferred from the introducer into the infusion catheter. The Codman Enterprise 2 is designed for use under fluoroscopy with the Prowler Select Plus Infusion Catheter (a 0.021” inner diameter, 5 cm distal length infusion catheter manufactured by Codman Neuro).
Indications for Use
The Codman Enterprise 2 Vascular Reconstruction Device is intended for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of ≥2.5 mm and ≤4 mm. Wide-neck is defined as having a neck width ≥4 mm or a dome-to-neck ratio <2.
For more information regarding the Humanitarian Device please contact the neurointerventionalists Israel Alba, MBA at 915-215-4616 to schedule a conference call with one of our Interventionist Neurologist or to schedule a Clinic Visit please contact our Clinic office Manager, Arlene Caro at 915-215-5909.
Wide neck aneurysms are difficult to treat both surgically and endovascular with clipping and this technique may be difficult or impossible if there is no true neck present. Coiling involves endovascular placement of embolic coils into the aneurysm sac, but aneurysm with wide necks cannot often structurally retain embolization coils and complications such as protrusion of the coil into the parent artery may occur.
Device Description
The LVIS Device is intended for use with bare platinum embolic coils for the treatment of un-ruptured, wide neck (neck > 4 mm or dome to neck ratio < 2), intracranial, secular aneurysms arising from a parent vessel with a diameter >2.5 mm and < 4.5 mm.
The LVIS device consist of a self-expanding nickel-titanium, single wire braid, compliant closed cell implant that can be deployed and retrieved by a single operator.
Indication for use
Endovascular therapy of wide neck aneurysms is sometimes limited to parent artery occlusion, if there adequate collateral flow or by a balloon-assisted technique. Availability of neurovascular stents through the Humanitarian Device Exemption regulatory provision has provided for an additional approach to aneurysm occlusion using endovascular techniques. Recently, a device, intracranial aneurism flow diverter, has been made available, but the device is limited to large or giant wide necked aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. If left untreated, aneurysms can rupture, causing death or significant morbidity.
For more information regarding the Humanitarian Device please contact the research coordinator Israel Alba, MBA at 915-215-4616 to schedule a conference call with one of our neurointerventionalists or to schedule a Clinic Visit please contact our Clinic office Manager, Arlene Caro at 915-215-5909.
Wide neck aneurysms are difficult to treat both surgically and endovascular with clipping and this technique may be difficult or impossible if there is no true neck present. Coiling involves endovascular placement of embolic coils into the aneurysm sac, but aneurysm with wide necks cannot often structurally retain embolization coils and complications such as protrusion of the coil into the parent artery may occur.
Device Description
The LVIS Device is intended for use with bare platinum embolic coils for the treatment of un-ruptured, wide neck (neck > 4 mm or dome to neck ratio < 2), intracranial, secular aneurysms arising from a parent vessel with a diameter >2.5 mm and < 4.5 mm.
The LVIS device consist of a self-expanding nickel-titanium, single wire braid, compliant closed cell implant that can be deployed and retrieved by a single operator.
Indication for use
Endovascular therapy of wide neck aneurysms is sometimes limited to parent artery occlusion, if there adequate collateral flow or by a balloon-assisted technique. Availability of neurovascular stents through the Humanitarian Device Exemption regulatory provision has provided for an additional approach to aneurysm occlusion using endovascular techniques. Recently, a device, intracranial aneurism flow diverter, has been made available, but the device is limited to large or giant wide necked aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. If left untreated, aneurysms can rupture, causing death or significant morbidity.
For more information regarding the Humanitarian Device please contact the research coordinator Israel Alba, MBA at 915-215-4616 to schedule a conference call with one of our neurointerventionalists or to schedule a Clinic Visit please contact our Clinic office Manager, Arlene Caro at 915-215-5909.
The Neuroform Atlas (Stryker Neurovascular, Fremont, USA) stent is a successor to the Neuroform stent as the first approved stent for aneurysm treatment. It is intended for the treatment of aneurysms on small parent vessels ranging from 2 to 4.5mm. It gained its CE mark in May 2015. Similar to other microstents (Leo Baby, LVIS Jr, and Acclino flex), it can be delivered through standard coiling catheters down to an inner diameter of 0.0165 inches.
Device description
The Neuroform Microdelivery Stent System includes:
A self-expanding, nitinol stent with four radiopaque markerbands on each end (distal and proximal). The stent is available in 2 interconnect (original configuration) and 3 interconnect configurations. The 3 interconnects create an additional link between the stent cells, provide better support of the coil mass within the aneurysm, and minimize stent deflection.
- A flexible over-the-wire 3F Microdelivery Catheter with a distal tip markerband. The stent and peelable sheath is preloaded into the distal end of the 3F Microdelivery Catheter.
- A 2F Stabilizer Catheter with a distal tip markerband. The 2F Stabilizer Catheter maintains the stent position during deployment.
- A Peelable Sheath to aid in the insertion of the guidewire into the 3F Microdelivery Catheter. The peelable sheath is preloaded into the tip of the 3F Microdelivery Catheter.
- Rotating Hemostasis Valves (RHVs), one provided with the 3F Microdelivery Catheter and one provided with the 2F Stabilizer Catheter. This system is available in two specific packaging configurations:
- Neuroform 2 Microdelivery Stent System is available with the 2 interconnect stent only.
- Neuroform 3 Microdelivery Stent System is available with the 3 interconnect stent only and is packaged with the components preassembled. Although there are two specific packaging configurations, all references in this DFU apply to both configurations unless stated otherwise.
Indication for use
The Neuroform Microdelivery Stent System is for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥2 mm and ≤4.5 mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck ≥4 mm or a dome-to-neck ratio of <2.
For more information regarding the Humanitarian Device please contact the research coordinator Israel Alba, MBA at 915-215-4616 to schedule a conference call with one of our neuroinveterventionalists or to schedule a Clinic Visit please contact our Clinic office Manager, Arlene Caro at 915-215-5909.
The Wingspan Stent System with Gateway PTA Balloon Catheter is a self-expanding, neurovascular, nitinol Stent and Delivery System and Balloon Catheter that consists of the following components:
- Wingspan Stent
- Wingspan Delivery System
- Gateway PTA Balloon Catheter
A detailed description of each of the three components of the Wingspan Stent System with Gateway PTA Balloon Catheter follows:
Wingspan Stent - The Stent has a tubular mesh (zigzag struts) design. Along the length of the Stent, several individual sections self-expand as the Stent deploys. Sections are joined by 2 interconnecting struts. It is made from nitinol. There are 8 radiopaque markerbands, 4 per end, which are secured to tabs on the Stent. The Stent is available in five diameters (2.5mm to 4.5mm) and three lengths (9mm, 15mm, and 20mm).
Wingspan Delivery System - The Delivery System is used to deliver the Stent to the treatment site within the patient's artery. The Delivery System is a single lumen, overthe-wire, coaxial microcatheter. The material composition of the catheter shaft changes over the length of it to create three distinct stiffness regions: proximal, middle, and distal. The proximal end has a strain relief and standard, female Luer fitting. The Delivery System is hydrophilically pass coated.1 The Delivery System is provided sterile with the Stent preloaded. The shaft has an overall nominal working length of 135cm.
For more information regarding the Humanitarian Device please contact the research coordinator Israel Alba, MBA at 915-215-4616 to schedule a conference call with one of our neurointerventionalists or to schedule a Clinic Visit please contact our Clinic office Manager, Arlene Caro at 915-215-5909.
The objective of this study is to assess the safety and probable benefit of the Neva VS device (a modified stent retriever) in patients presenting with symptomatic cerebral vasospasm despite maximal medical management following aSAH. The NeVa VS is a percutaneously introduced transluminal cerebral artery dilatation device that is temporarily inserted into the cerebral vasculature for the dilation of targeted vessels to treat SAH induced vasospasm. The overall operation and deployment of the NeVa VS follows the same basic principles and procedures as for use of stent retrievers.
The study is funded by Vesalio (dba of Legacy Ventures LLC).
The primary investigator (Pl) is Alberto Maud, M.D., and Co-Investigator Gustavo J. Rodriguez, M.D.
For more information regarding the clinical trial, please contact the Research Director, Dr. Susana Villalobos at Susana.villalobos@ttuhsc.edu. Or Israel Alba, MBA, CCRP, Clinical Research Coordinator lsrael.alba@ttuhsc.edu
Neuroform Indication for Use: Authorized by Federal law for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of =2mm and =4.5mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck =4mm or a dome-to-neck ratio of <2. The effectiveness of this device for this use has not been demonstrated.
The study is funded by Stryker Neurovascular.
The primary investigator (Pl) is Alberto Maud, M.D., and Co-Investigator Gustavo J. Rodriguez, M.D.
For more information regarding the clinical trial, please contact the Research Director, Dr. Susana Villalobos at Susana.villalobos@ttuhsc.edu. Or Israel Alba, MBA, CCRP, Clinical Research Coordinator lsrael.alba@ttuhsc.edu
Stroke is the third most common cause of death in the United States and one of the most disabling neurological disorders. Approximately 795,000 patients suffer from stroke annually and 87% of patients present with ischemic stroke which is caused by emboli or thrombus occlusion of neurovascular vessels. Large vessel occlusions (LVOs) account for up to 46% of acute ischemic strokes. Further, given that LVOs entail significant blockage, they represent a disproportionate percentage of the morbidity and mortality associated with acute ischemic stroke. There is, therefore, a significant opportunity to improve patient outcomes on a large scale.
Intravenous tissue plasminogen activator (tPA) therapy improves outcomes in acute ischemic stroke. However, use of this medical therapy also carries the risk for intracranial hemorrhage (ICH), the worst complication of thrombolysis. Recently, five randomized trials showed efficacy of endovascular mechanical thrombectomy over standard medical care alone in patients with acute ischemic stroke (MR CLEAN, ESCAPE, REVASCAT, SWIFT PRIME, EXTEND IA). Successful recanalization rates (mTICI 2b/3) in the interventional arms were superior to standard medical care alone and ranged between 58% - 86%.
The NeVa family of stent retrievers is a new line of retrievers designed by Vesalio that may represent a next generation of stent retrievers. Early animal data are highly suggestive of the fact that the NeVa stents may be able to recanalize an occluded vessel with fewer passes and have enhanced ability to retrieve organized clots. The objective of this pivotal study is to compare the performance of the NeVa stent retrievers to other commercially available stent retrievers.
The study is funded by Vesalio (dba of Legacy Ventures LLC).
The primary investigator (Pl) is Alberto Maud, M.D., and Co-Investigator Gustavo J. Rodriguez, M.D.
For more information regarding the clinical trial, please contact the Research Director, Dr. Susana Villalobos at Susana.villalobos@ttuhsc.edu. Or Israel Alba, MBA, CCRP, Clinical Research Coordinator lsrael.alba@ttuhsc.edu