California’s Hansen Medical (NSDQ:HNSN) said it won CE Mark approval in the European Union for treating peripheral artery disease with a new, larger version of its Magellan robot-assisted surgery platform.
Mountain View-based Hansen said the regulatory nod is for its 10-French robotic catheter, designed with the the largest inner lumen of any Magellan catheter at 7-French.
Last February, Hansen won FDA clearance for a 6-French Magellan catheter that is also paired with the Magellan system. President & CEO Cary Vance said the 10-French catheter will help boost adoption of the Magellan system.
"We are focused on broadening the capabilities and utility of the Magellan robotic system in the minimally-invasive treatment of vascular disease. With this new catheter, our physician and hospital customers can expand utilization of Magellan," Vance said in prepared remarks.
In March, Hansen raised $35 million in a private placement from a syndicate including its founder, a director and a pair of hedge funds. The funding round includes convertible stock and warrants worth another $52.5 million, and so the grand total could hit $87.5 million if the warrants are exercised.
