The treatment of acute ischemic stroke and brain aneurysms is rapidly evolving. New transcatheter devices and adjuvant imaging promising to improve outcomes and reduce the burden of neurovascular disease. However, to really spur this market, long-term, large-scale clinical trials are needed.
Neurointerventional Device Update: The Burgeoning Stroke Toolbox
Article preview from Medtech Insight - September, 2012
Approximately 795,000 new or recurrent strokes will occur this year in the US – or one every 40 seconds. And, by 2030, an additional four million Americans will have had a stroke, a 24.9% increase in prevalence from 2010, according to the latest American Heart Association (AHA) projections. Stroke is the fourth leading cause of death in the US, killing 200,000 people each year, and a leading cause of serious long-term adult disability, with over seven million people over age 20 living with the consequences of stroke, according to the AHA. Approximately 87% of strokes are ischemic (caused by a blood vessel blockage in the brain), and as of only a decade ago intravenous therapy with the thrombolytic drug tissue plasminogen activator (tPA) was the only real treatment option for these patients. Now however, minimally invasive, neurointerventional procedures are shifting the treatment paradigm – for ischemic stroke as well as brain aneurysms – and have created promising new device markets that are attracting established, acquisition-minded players as well as innovative start-ups. A number of positive developments in this space were presented at the Society of NeuroInterventional Surgery (SNIS) 9th Annual Meeting, held in July in San Diego, CA, and so far this year two next-generation mechanical clot-retrieval devices have received US Food and Drug Administration (FDA) approval, with other neurointerventional devices debuting internationally.
According to industry players and researchers in this space, neurointerventional devices to directly address blood clots in the brain are on their way to becoming one of the most impactful and high-growth device markets. In fact, in a study out of West Virginia University, presented at the SNIS, endovascular therapy (EVT) was associated with significantly better treatment outcomes compared with traditional intravenous tPA (IVT) for patients suffering acute ischemic stroke resulting from blockages in the large, more high-risk vessels of the brain. In the single-center retrospective study that assessed outcomes from 223 patients over an eight-year period from 2003 to 2012, data showed that patients treated with EVT experienced more favorable outcomes than IVT, 44.7% vs. 26%, respectively. The researchers concluded that there is an urgent need for randomized trials for EVT versus IVT, an initiative that could “transform our treatment approach to this disease.”
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