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news.Micrus Endovascular has announced that the Vitesse intracranial stent study for ischemic therapy clinical trial application has received conditional approved from the FDA.
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The Pharos Vitesse intracranial stent is Micrus Endovascular’s second balloon-expandable stent for the treatment of intracranial ischemic stenosis and is the subject of an investigational device exemption (IDE) study designed to compare the clinical outcomes between patients treated with the stent and another medical therapy. The company is in the process of initiating study sites in the US, Europe and China.
The Pharos Vitesse is manufactured exclusively for Micrus Endovascular through a collaborative agreement with Switzerland-based Biotronik. According to the company, the Vitesse stent enables the intracranial delivery and deployment of a stent in one step, eliminating the need for pre-dilation of constricted vasculature.
John Kilcoyne, chairman and CEO of Micrus Endovascular, said: “Our second-generation Pharos Vitesse stent is designed with a series of technical advances for improved handling and navigability and also incorporates a proprietary coating that we believe may reduce the need for retreatment due to restenosis.”