Hansen Medical’s Magellan Robotic System Receives FDA Clearance

Hansen Medical recently declared that its Magellan Robotic System, inclusive of catheter and accessories, has achieved 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Following this clearance, the company will instantly start commercialization at specific centers across the U.S. However, its full launch is scheduled in 2012 end. The product will be demonstrated from June 7 to 9 at the 66^th Vascular Annual Meeting of the Society for Vascular Surgery at National Harbor, Maryland.

The Magellan Robotic System ensures efficient access across anatomical targets within the peripheral vasculature followed by creating a conduit for therapeutic devices that can be placed manually. Using this unique system, vascular surgeons can rapidly perform predictable procedures without being affected by radiation exposure.

Among 3 M vascular procedures accomplished each year, around one-third to one-half of deploy the Magellan Robotic System.

A new standard for peripheral vascular intervention has been created by the Magellan Robotic System. It features solid catheter stability, revolutionary lesion access, consistent procedural efficiency and precise distal tip control.

The Magellan platform will ensure hospitals with compelling value proposition.

In 2011, the Magellan System achieved a CE Mark in the EU, followed by commercial launch in that state. The system has received approval in Australia, with a pending approval in Canada.

Based on the flexible robotic technology integrated in the Sensei-X Robotic Catheter System, Hansen Medical's Magellan Robotic System features increased case throughput ensuring predictable procedure times; maintains Sensei System’s open architecture enabling subsequent use of many 6F therapeutic devices on the existing market; and offers solid catheter stability for placing therapeutic devices. Furthermore, it ensures independent robotic control of the distal tips of inner leader catheter and outer sheath in addition to robotic manipulation of standard guidewires. It can be extended inside the body to navigate complex peripheral anatomy.

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