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news.Micrus Endovascular, a medical device company, has enrolled the first patient in the Vitesse intracranial stent study for ischemic therapy, an investigational device exemption study designed to compare clinical outcomes between patients treated with the company's Pharos Vitesse balloon expandable stent and the current best medical practice.
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The Vitesse intracranial stent study for ischemic therapy (VISSIT) clinical trial is designed to include up to 250 patients who demonstrate ischemic symptoms attributable to stenosis of an intracranial artery.
The trial will be conducted at a total of 30 sites in the US, Europe and China. Trial completion is anticipated in approximately 30 months, with full enrollment expected between 12 months and 15 months and each patient evaluated during a 12-month post-treatment follow-up period.
According to the company, the Pharos Vitesse enables the intracranial delivery and deployment of a stent in one step, eliminating the need for pre-dilation of constricted vasculature. The Pharos Vitesse is manufactured exclusively for Micrus Endovascular through a collaborative agreement with Switzerland-based Biotronik.
John Kilcoyne, chairman and CEO of Micrus Endovascular, said: “This is the first global, industry-sponsored prospective, randomized clinical trial to evaluate the safety and effectiveness of an intracranial stent for stenoses caused by intracranial atherosclerotic disease, which are responsible for 8% to 10% of all strokes.”