The purpose of this technology transfer application is to initiate pre-clinical testing of a novel flow-diverting stent for the treatment of intracranial aneurysms developed at UCLA. Intracranial aneurysms are spherical out- pouchings of blood vessels in the head. The exact prevalence of unruptured intracranial aneurysms is unknown but estimates place it between 2 and 3 percent of the general population. Aneurysm rupture results in a high rate of morbidity and mortality, and unruptured intracranial aneurysms are generally treated using either surgical or endovascular approaches. The endovascular coiling approach is currently used to treat ~2/3 of intracranial aneurysms, and is preferred by patients and healthcare providers alike because of its non-invasive nature. Endovascular coiling, however, suffers from a number of deficiencies such as aneurysm recanalization and an inability to treat certain morphologies. The purpose of this 2-year, Phase I STTR is to initiate pre-clinical testing of a new endovascular Thin Film Nitinol (TFN) covered stent developed at UCLA for the replacement of endovascular coils in the treatment of intracranial aneurysms. The TFN covered stent consists of a hyperelastic thin film nitinol (HE-TFN) material attached to a neurovascular stent and packaged into an ultra-low profile catheter sufficiently flexible to navigate the tortuous anatomy of the neurovascular system. The HE-TFN covered stent is deployed over the neck of an aneurysm to produce rapid occlusion of the anuersym sac. In vivo studies have shown that this device leads to complete angiographic occlusion in as little as 5 minutes. This result is significantly superior to data published for other neurovascular devices. Therefore, our HE-TFN covered stent graft is an effective flow diverting technology for the treatment of intracranial aneurysms with significant advantages over competitors and a high likelihood of commercial success in a large and growing market. The focus of this 2 year technology transfer application is to initiate pre-clinical testing of a novel flow-diverting stent for the treatment of intracranial aneurysms. This project will proceed through a series of well defined five tasks with milestones. These include a thorough review of endovascular device manufacturing procedures, development of a stent fabrication facility, in vitro and in vivo testing of the prototype device according to GLP standards, and preparation of a report on our findings. Phase II of this STTR application will focus on finalization of pre-clinical results, submission to FDA for an investigational device exemption and, ultimately, full-scale clinical trials.
Public Health Relevance: Intracranial aneurysms are a spherical out-pouchings of blood vessels in the head that result from a localized weakness in the vessel wall. The exact prevalence of unruptured intracranial aneurysms is unknown but most estimates place it between 2 and 3 percent of the general population. Rupture of these aneurysms is often devastating, resulting in a hemorrhagic stroke that can cause severe disability and death. Current endovascular approaches to treating intracranial aneurysms suffer from a high rate of failure and an inability to treat certain aneurysm morphologies. The purpose of this technology transfer application is to initiate pre-clinical testing of a flow-diverting stent for the treatment of intracranial aneurysms. This stent will provide a more durable and versatile repair than current techniques and has the potential to significantly alter clinical practice patterns for this common and disabling disease process.
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