Hansen Medical wins 510(k) for Magellan 10Fr catheter

Hansen Medical (NSDQ:HNSN) said yesterday it won FDA 510(k) clearance for its Magellan 10Fr robotic catheter with indications for use in the peripheral vasculature.

The Mountain View, Calif.-based company’s robotic catheter is designed to navigate the peripheral vasculature and provide a conduit for the placement of therapeutic devices, Hansen Medical said. The catheter operates as part of Hansen’s Magellan robotic system.

The Magellan robotic system is a platform that drives Magellan robotic catheters and guide wires during minimally invasive, endovascular procedures, the company said.

“We have been eagerly anticipating having access to the Magellan 10Fr robotic catheter. Our team has found significant clinical value in the Magellan system to predictably navigate tortuous vascular anatomy and provide a stable platform during treatment. The 10Fr catheter, with its larger inner lumen, will enable us to broaden our use of Magellan to include many additional procedures in which the delivery of stents, balloons or other devices requires a 7Fr catheter inner lumen,” Dr. Fred Weaver of the Keck Hospital of the University of Southern California said in a press release.

“We are excited to introduce the Magellan 10Fr robotic catheter to our customers in the United States. We believe that robotic technology offers the potential to transform how endovascular treatment is performed, by bringing enhanced control and predictability to procedures, and by addressing serious occupational hazards faced by physicians and their teams in the delivery of patient care. With this new catheter, we expect that many more patients will now be able to benefit from procedures with the Magellan Robotic System,” CEO Cary Vance said in prepared remarks.

Hansen won CE Mark approval for the catheter in April, and has been used in procedures in Australia, Germany and the U.K. since its approval, the company said.

In April, Hansen also said it won CE Mark approval in the European Union for a new, larger version of its Magellan robot-assisted surgery platform for use in treating peripheral artery disease.

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