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Hansen Medical files with FDA for expanded neurological indication for Magellan robotic product line

Press releases may be edited for formatting or style | April 26, 2016
MOUNTAIN VIEW, CA--(Marketwired - Apr 26, 2016) - Hansen Medical®, Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today provides an update on the status of its key corporate initiative to expand the utility and regulatory labeling of the Magellan™ product line.

Hansen Medical recently submitted a 510k to the FDA for a neurological indication for the Magellan Robotic System. If successful, the Magellan Robotic System would be fully indicated for applications in peripheral vascular and neurological procedures.

"Our experience in performing robotically assisted carotid stent procedures has shown that there could be important advantages for neuro applications including many of the benefits we have seen in other applications, like embolization and other endovascular therapies," said Barry T. Katzen, MD of Miami Cardiac & Vascular Institute in Miami, FL.

"We anticipate that an added neurological indication would allow us to bring the benefits of robotics to a new specialty of physicians who could, in turn, offer robotic solutions to a new patient population," said Cary Vance, Hansen Medical's President and Chief Executive Officer. "We are excited by the potential to expand the procedure base in which robotics can play a role."

About the Magellan™ Robotic System
Hansen Medical's Magellan Robotic System is intended to be used to facilitate navigation in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic System is designed to deliver predictability, control and catheter stability to endovascular procedures. Since its commercial introduction in the U.S. and Europe, the Magellan Robotic System has demonstrated its clinical versatility in many cases in a broad variety of peripheral vascular procedures globally. The Magellan Robotic System offers several important features including:
Provides predictability, control and catheter stability as a physician navigates a patient's peripheral vasculature and then provides a conduit for manual treatment of vascular disease with standard therapeutic devices.

Is designed to enable more predictable procedure times and increased case throughput potentially allowing hospitals to improve utilization within their vascular business line.

Employs an open architecture designed to allow for the subsequent use of many therapeutic devices on the market today.

Is designed to potentially reduce physician radiation exposure and fatigue by allowing the physician to navigate procedures while seated comfortably at a remote workstation away from the radiation field and without wearing heavy lead as required in conventional endovascular procedures.

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