Technology | June 05, 2012

FDA Clears Hansen Magellan Robotic System for Peripheral Vascular Interventions

Company to Commence Commercial Launch in the United States

June 5, 2012 — Hansen Medical Inc. received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for its Magellan Robotic System, the first robotic navigation system to more precisely guide peripheral artery disease (PAD) interventions in the cath lab. The approval includes the catheter and accessories for the system. The company will commence commercialization at selected centers in the United States 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 in Maryland from June 7-9.

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. 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.”

The global vascular market is large and expanding rapidly, driven by an aging population, the prevalence of diabetes and obesity, and an increase in disease awareness. 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.

“The Magellan Robotic System is a significant technological advancement that may offer important clinical benefits for physicians performing peripheral interventions," said Alan Lumsden, M.D., chair of Hansen Medical’s U.S. 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. "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 offers a new way to perform peripheral vascular interventions that has the potential to deliver revolutionary lesion access, precise distal tip control, solid catheter stability and consistent procedural efficiency.

“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," said Jean Bismuth, M.D., vascular surgeon at the Methodist DeBakey Heart and Vascular Center at The Methodist Hospital. "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 that want to boost their profile with the regions they serve. Similar to the da Vinci surgical robotic system that many hospitals use as an advertising tool to draw more patients, the Magellan may have a similar marketing utility.

“Hospitals today need to ensure not only quality patient care, but also sound fiduciary judgment in all purchase decisions,” said 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.”

The Magellan system received a CE Mark in the European Union last year. In addition, the system has been approved in Australia and is pending approval in Canada.

Hansen previously developed and released the Sensei robotic system to support long electrophysiology mapping and ablation procedures. 

For more information: www.hansenmedical.com

Related Content

Corindus and Mayo Clinic Conducting Preclinical Telestenting Study of Remote PCI Capabilities
News | Robotic Systems | January 08, 2018
Corindus Vascular Robotics Inc. announced that it is working with Mayo Clinic in a preclinical study about use of...
Corindus and Houston Methodist DeBakey Heart & Vascular Center Launch Robotic Training Site
News | Robotic Systems | December 28, 2017
Corindus Vascular Robotics Inc. announced recently that Houston Methodist DeBakey Heart & Vascular Center has...
Robocath Receives $1.5 Million in Capital for Advancement of R-One Robotic System
News | Robotic Systems | December 06, 2017
December 6, 2017 — French company Robocath, which designs and develops...
Montreal Heart Institute Performs First Robotic Mitral Valve Surgery
News | Robotic Systems | September 22, 2017
The Montreal Heart Institute (MHI) announced the acquisition of the da Vinci Xi, a new-generation surgical robot, and...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems | September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Large Multicenter Study Shows High Success Rate for Robotic PCI Procedures, SCAI, Corindus CorPath 200
News | Robotic Systems | May 16, 2017
The largest real-world study of robotic percutaneous coronary intervention (PCI) demonstrated clinical and technical...
Robotic-Assisted PCI With CorPath GRX Broadcast Live at TCT Asia-Pacific Summit
News | Robotic Systems | May 01, 2017
Corindus Vascular Robotics Inc. announced that Fu Wai Hospital in China performed and broadcast live a percutaneous...
Clinical Study Validates Efficiencies of Stereotaxis Niobe ES System Over Niobe II System
News | Robotic Systems | April 24, 2017
A recent study conducted at Centre Hospitalier Universitaire (CHU) of Saint-Étienne, France validated the advantages of...
Corindus Announces First Robotic-Assisted PCI Procedures Performed in Asia Using CorPath GRX System
News | Robotic Systems | April 12, 2017
Corindus Vascular Robotics Inc. announced that the first robotic-assisted percutaneous coronary intervention (PCI)...
Stereotaxis, Niobe remote magnetic navigation system, Philips Allura Xper FD10 cardiovascular X-ray, interface, integration
News | Robotic Systems | January 20, 2017
Stereotaxis Inc. announced the release of an interface between its remote magnetic navigation system for...
Overlay Init