Hansen Medical Inc. (HNSN) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Magellan Robotic System, including the catheter and accessories.
The company said it will commence commercialization at selected centers in the U.S. immediately, with a full launch expected later in the year.
The product will be presented at the 66th Vascular Annual Meeting of the Society for Vascular Surgery at National Harbor, Maryland from June 7-9.
The Magellan Robotic System is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.
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