Clinical Research & Publications
Research with a new level of insight
For over two decades, virtual medical simulators and physiological flow systems have been featured in a variety of publications as a key tool for medical device and procedural research and curriculum development to facilitate medical professionals.
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The WEB Intra-saccular Therapy (WEB-IT) trial is an investigational device exemption study to demonstrate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. The neurovascular replicator (Vascular Simulations, Stony Brook, New York, USA) creates a physical environment that replicates patient-specific neurovascular anatomy and hemodynamic physiology, and allows devices to be implanted under fluoroscopic guidance.
Multiple studies have shown the benefit of simulator use for medical trainees. In the endovascular realm, this has been demonstrated in the cardiac, vascular and neurovascular literature with both computer simulation models and physical models of the vasculature. In this study, the authors investigate the feasibility of a customized 3D model, not for training purposes, but for rehearsal prior to an actual endovascular treatment procedure.
Biplane angiography systems provide time resolved 2D fluoroscopic images from two different angles, which can be used for the positioning of interventional devices such as guidewires and catheters. The purpose of this work is to provide a novel algorithm framework, which allows the 3D reconstruction of these curvilinear devices from the 2D projection images for each time frame. This would allow creating virtual projection images from arbitrary view angles without changing the position of the gantries, as well as virtual endoscopic 3D renderings.
The use of simulators has been described in a variety of fields as a training tool to gain technical skills through repeating and rehearsing procedures in a safe environment. In cerebrovascular surgery, simulation of skull base approaches has been used for decades. The use of simulation in neurointervention to acquire and enhance skills before treating a patient is a newer concept, but its utilization has been limited due to the lack of good models and deficient haptics. The advent of 3D printing technology and the development of new training models has changed this landscape.
We sought to develop a standardized curriculum capable of assessing key competencies in Interventional Neuroradiology by the use of models and simulators in an objective, quantitative, and efficient way. In this evaluation we analyzed the associations between the practical experience, theoretical knowledge, and the skills lab performance of interventionalists.
Transcatheter aortic valve replacement (TAVR) is an over-the-wire procedure for treatment of severe aortic stenosis (AS). TAVR valves are conventionally tested using simplified left heart simulators (LHS). While those provide baseline performance reliably, their aortic root geometries are far from the anatomical in situ configuration, often overestimating the valves’ performance. We report on a novel benchtop patient-specific arterial replicator designed for testing TAVR and training interventional cardiologists in the procedure. The Replicator is an accurate model of the human upper body vasculature for training physicians in percutaneous interventions.
Flow diverters are increasingly used to treat a broad category of cerebral aneurysms. We conducted an in vitro study to angiographically compare the flow diversion effect of Surpass Evolve from Stryker Neurovascular with the Pipeline Shield Embolization Device from Medtronic Neurovascular.
The increased adoption of endovascular neurosurgery procedures to treat cerebrovascular pathologies has led to the commercialization of a wide array of medical devices which, in turn, necessitates a more sophisticated training environment for physicians and fellows than the traditional “see one, do one, teach one” concept. Improvements in simulation technology and a changing healthcare culture are facilitating a wider assimilation of benchtop simulation models in lieu of cadaver or animal models in physician training as well as treatment planning. Medical device manufacturers as well as regulators are also increasingly utilizing such simulators for device development and assessment of efficacy.
