Hansen Medical has announced it has received FDA 510(k) clearance for its Magellan Robotic System for peripheral vascular interventions, according to a news release.
The system is designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, according to the company.
The FDA clearance includes the catheter and accessories. Hansen Medical expects a full launch of the system later in the year.
"Today's announcement marks one of the most significant milestones in the company's history," said Hansen Medical President and CEO Bruce Barclay, in the release. "Not only does the Magellan System have the potential to be a significant growth driver for Hansen, it also represents a fundamental step forward in the transformation of vascular intervention using intravascular robotics."
Hansen Medical is headquartered in Mountain View, Calif.
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