LVIS

LVIS

LVIS is a microbraided, self-expanding neurovascular stent system used in endovascular treatment of intracranial aneurysms and parent artery reconstruction. It is applied in combination with coil embolization and adjunctive techniques during endovascular procedures performed by interventional neuroradiologists and endovascular neurosurgeons. The device has been evaluated in clinical studies and regulatory submissions across multiple jurisdictions including the European Union and the United States.

Overview

LVIS devices are deployed via microcatheter platforms during procedures in catheterization laboratories and hybrid operating rooms overseen by specialists from institutions such as Massachusetts General Hospital, Mayo Clinic, Johns Hopkins Hospital, Cleveland Clinic, and Charité – Universitätsmedizin Berlin. Their introduction followed innovations exemplified by devices like Enterprise stent, Pipeline Embolization Device, Neuroform stent, and Woven EndoBridge that advanced endovascular management of aneurysms after landmark trials including ISAT and registries such as CLARITY study. Adoption has involved collaboration among societies including the Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and specialty conferences such as SNIS Annual Meeting and ESMINT Congress.

Technology and Design

The LVIS family uses braided nitinol wires providing radiopacity via incorporated strands similar to technologies in devices like Enterprise 2 (Codman & Shurtleff), Acandis Acclino, and Silk stent. Design elements enable varying porosity and metal coverage to facilitate flow diversion comparable in intent to devices such as the Pipeline Flex and Flow Re-Direction Endoluminal Device. Delivery is achieved through compatible microcatheters modeled on platforms like Excelsior SL-10 and Headway Duo, and deployment techniques draw from skill sets used for coiling adjuncts and complex catheter navigation strategies involving Roadmap (angiography) and 3D rotational angiography from systems by Siemens Healthineers, GE Healthcare, and Philips Healthcare. Device sizes and radiopaque markers were developed to address anatomy encountered in territories supplied by the anterior communicating artery, middle cerebral artery, posterior communicating artery, and basilar artery branches. Engineering considerations incorporate lessons from stent designs used in coronary stenting like those by Boston Scientific and Abbott Laboratories regarding foreshortening, radial force, and fatigue resistance.

Clinical Applications and Efficacy

LVIS is indicated for assisted coil embolization of wide-necked saccular aneurysms located in intracranial vasculature including regions served by the internal carotid artery and vertebrobasilar circulation. Clinical evaluations include prospective registries and single-center series comparing outcomes with adjunctive techniques such as balloon-assisted coiling used in procedures influenced by protocols from International Subarachnoid Aneurysm Trial investigators. Efficacy endpoints assessed in studies mirror those in trials like PUFS and IntrePED, including occlusion rates, retreatment frequency, and modified Rankin Scale outcomes commonly reported by centers like UCLA Medical Center and Toronto Western Hospital. Reported complete angiographic occlusion and Raymond–Roy classifications often inform consensus statements from groups including American Heart Association and European Stroke Organization when formulating practice guidelines that reference devices such as LVIS Junior alongside alternatives like SILK+ and FRED flow diverter.

Safety and Complications

Complication profiles include thromboembolic events, in-stent stenosis, parent vessel occlusion, and procedure-related hemorrhage, complications similarly observed with devices like Pipeline', Neuroform Atlas, and Solitaire FR when used in cerebrovascular interventions. Periprocedural management commonly involves antiplatelet regimens guided by protocols informed by trials such as MATCH trial and platelet function testing technologies like VerifyNow; multidisciplinary perioperative care often involves teams from Neurosurgery departments at tertiary centers like Mount Sinai Hospital and Royal Melbourne Hospital. Long-term surveillance strategies employ follow-up imaging modalities including digital subtraction angiography, magnetic resonance angiography, and computed tomography angiography used in outcome assessments in registries overseen by organizations such as EudraVigilance and national neurointerventional registries.

Regulatory Approval and Availability

Regulatory pathways for LVIS included submissions to the Food and Drug Administration and conformity assessment under CE marking for Europe, paralleling clearance processes experienced by contemporaneous devices from companies like Stryker Corporation, Medtronic, and MicroVention. Availability varies by country and institution, with distribution and training programs often coordinated with academic centers including Harvard Medical School, Stanford University School of Medicine, and Imperial College London for proctoring and credentialing. Post-market surveillance, investigator-initiated studies, and registry data continue to inform recommendations by professional bodies including SNIS and ESMINT regarding device selection relative to alternatives such as flow diverters and adjunctive stent-assisted coiling techniques.

Category:Neurointerventional devices