Hansen Medical (HNSN) Receives FDA 510(k) Clearance for Magellan 10Fr Robotic Catheter

July 1, 2015 4:34 PM EDT
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Hansen Medical (NASDAQ: HNSN) today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Magellan" 10Fr Robotic Catheter for use in the peripheral vasculature. The FDA clearance enables the company to initiate clinical use of the 10Fr catheter with its customers in the United States.

The Magellan 10Fr Robotic Catheter is the latest addition to the family of robotic catheters used with the Magellan Robotic System. The 10Fr catheter allows for independent, robotic control of two telescoping catheters (an outer Guide and an inner Leader catheter). The Guide catheter has a 10Fr outer diameter, and features the largest inner lumen (7Fr) in the Magellan catheter family, which enables delivery of therapeutic devices through the robotic catheter in a broader range of endovascular procedures. The company received CE Mark approval for the 10Fr catheter in April 2015, and procedures have subsequently been performed with the device in Australia, Germany and the United Kingdom.

"We have been eagerly anticipating having access to the Magellan 10Fr Robotic Catheter," said Dr. Fred Weaver, Chief of Vascular Surgery and Endovascular Therapy at Keck Hospital of the University of Southern California (USC). "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."

The Magellan Robotic System is an advanced technology that drives Magellan Robotic Catheters and guide wires during minimally-invasive, endovascular procedures. Magellan is designed to offer procedural predictability, precision, and catheter stability as physicians navigate inside blood vessels and deliver therapy. Image-guided medical procedures using interventional fluoroscopy, while growing rapidly, are the leading source of occupational ionizing radiation exposure for medical personnel(1). Magellan's remote workstation allows physicians to control robotic catheters and guide wires while seated away from the radiation field, which has been shown to reduce radiation exposure for the physician by as much as 95% in complex endovascular procedures(2).

"We are excited to introduce the Magellan 10Fr Robotic Catheter to our customers in the United States," said Cary Vance, President and Chief Executive Officer of Hansen Medical. "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."

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