Hansen Medical receives FDA 510(k) clearance for its Magellan Robotic System for peripheral interventions

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On 4 June 2012, Hansen Medical announced that it has received 510(k) clearance from the FDA for its Magellan Robotic System, including the catheter and accessories. The company will commence commercialisation at selected centres in the US immediately, with a full launch expected later in the year. The product will be presented at the 66th Vascular Annual Meeting of the Society for Vascular Surgery at National Harbor, from 7–9 June.


The Magellan Robotic System is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. According to Hansen Medical, the system has the potential to provide vascular surgeons and other interventionalists the ability to perform fast and predictable procedures, while allowing the physician to be seated comfortably away from the radiation source, which may reduce radiation exposure and physician fatigue.


“Today’s announcement marks one of the most significant milestones in the company’s history,” said Hansen Medical president and CEO Bruce Barclay. “Not only does the Magellan System have the potential to be a significant growth driver for Hansen, it also represents a fundamental step forward in the transformation of vascular intervention using intravascular robotics.”


Of the more than 3 million vascular procedures done worldwide each year, approximately one-third to one-half of them could be addressed using the Magellan Robotic System, Hansen said.


Alan Lumsden, chair of Hansen Medical’s US Scientific Advisory Board, and chair of the Department of Cardiovascular Surgery and Medical Director of Methodist DeBakey Heart and Vascular Center at The Methodist Hospital, Houston, USA, commented, “The Magellan Robotic System is a significant technological advancement that may offer important clinical benefits for physicians performing peripheral interventions. The system provides physicians with independent robotic control of both catheter tips to navigate efficiently through a variety of anatomies and lesions. Our in vitro and in vivo animal studies indicate that using this platform has the potential to increase efficiencies in the interventional lab by shortening procedure times and allowing more predictable interventions. Ultimately, we believe this system may facilitate alternative patient treatment options by enabling robotic endovascular interventions.”


The Magellan Robotic System results in a new standard for peripheral vascular intervention that has the potential to deliver revolutionary lesion access, precise distal tip control, solid catheter stability and consistent procedural efficiency, Hansen Medical stated in a press release.


Jean Bismuth, vascular surgeon at the DeBakey Heart and Vascular Center at The Methodist Hospital, Houston, said, “Since the Magellan Robotic System was designed specifically for vascular interventions, it offers excellent catheter stability and precision during the delivery and placement of a variety of therapeutic devices in different anatomic conditions, including various peripheral vascular diseases with tortuous anatomy. Additionally, the Magellan Robotic System may offer physicians less radiation exposure and reduced procedural fatigue due to the remote workstation that allows the physician to be seated comfortably outside the imaging suite.”


The company believes the Magellan platform also provides a compelling value proposition to hospitals. “Hospitals today need to ensure not only quality patient care, but also sound fiduciary judgment in all purchase decisions,” continued Barclay. “To remain competitive in the markets they serve, hospitals need to become more efficient, while also increasing their patient capacity. The Magellan Robotic System has the potential to help hospitals accomplish both of these goals.”


“We are excited about the initial interest a number of key US hospitals have shown in the Magellan System and intend to focus our near-term commercialisation strategy on partnering with a select group of esteemed physicians who are both influential and early adopters of new technologies in the industry,” said Barclay. “We will provide them with the appropriate training and engage with them to demonstrate the benefit and value of the Magellan. This focused and controlled commercial launch should enable us to generate positive clinical experiences and data to drive both interest and adoption among other physicians and hospitals in the large and rapidly expanding US peripheral vascular market, and will be followed later this year with full launch activities.”


Barclay concluded, “Today’s announcement is a testament to the immensely talented development and support teams at Hansen Medical that worked tirelessly to reach this important milestone, and I want to personally congratulate and thank them for their hard work.” The Magellan System received a CE mark in the European Union last year, and the company has already commenced a commercial launch in that region. In addition, the system has been approved in Australia, and is pending approval in Canada.