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Hansen Medical obtains FDA clearance for Magellan 6Fr robotic catheter

Hansen Medical has received the US Food and Drug Administration (FDA) clearance for its smaller diameter Magellan 6Fr robotic catheter, designed for peripheral vascular interventions.

The Magellan 6Fr robotic catheter features new dual-bend technology, enabling independent robotic control of two separate bend sites on a single catheter, compared to the current Magellan 9Fr robotic catheter which is designed as a telescoping device with two, independently controlled robotic catheters.

The 6Fr catheter’s new design provides for precise robotic navigation and control in a single, smaller diameter 6Fr outer diameter catheter, and enables use of the Magellan robotic system in smaller vessels in the peripheral vasculature and by physicians who may prefer a smaller diameter vessel insertion site.

Hansen Medical CFO Peter J. Mariani said the Magellan 6Fr robotic catheter will enable company’s physician customers to apply the benefits of robotic precision, control and procedural predictability to the treatment of many more vascular patients, which is one of the fastest growing service lines in hospitals today.

"This new catheter demonstrates our commitment to expanding the potential clinical applications of Magellan, providing further support to the compelling return on investment potential associated with a multi-disciplinary Intravascular Robotics program," Mariani added.

The company said it will begin a limited release of the device, anticipating a more wide-scale release later in 2014.