Micrus Endovascular Receives FDA Approval for Intracranial Stent Clinical Trial
July 14, 2008 - Micrus Endovascular Corp. today said the Pharos Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) clinical trial application has been conditionally approved by the FDA.
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 U.S., Europe and China.
The company said its new stent is designed with advances for improved handling and navigability and incorporates a proprietary coating that we believe may reduce the need for retreatment due to restenosis.
The Pharos Vitesse is manufactured exclusively for Micrus Endovascular through a collaborative agreement with Switzerland-based Biotronik AG. It enables the intracranial delivery and deployment of a stent in one step, eliminating the need for pre-dilation of constricted vasculature.
For more information: www.micruscorp.com