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www.fdanews.com/articles/170808-hansen-medicals-robot-assisted-pad-catheter-gets-ce-mark

Hansen Medical’s Robot-Assisted PAD Catheter Gets CE Mark

April 15, 2015

Hansen Medical’s 10-French Magellan robot-assisted catheter for peripheral artery disease treatment has received CE Mark approval. It boasts the largest inner lumen of any in the Magellan catheter line, the Mountain View, Calif., devicemaker says.

The catheter is to be used in combination with the devicemaker’s Magellan surgery platform, which traverses peripheral blood vessels during endovascular surgeries. The system features guidewire steering and allows for the manual delivery of therapy. Health professionals may perform Magellan procedures remotely, safely away from radiation, the company claims.

Last year, Hansen’s 6-French Magellan catheter received FDA 510(k) clearance. — Jason Scott