Hansen Medical declared that its Magellan Robotic System was successful in completing the European Union conformity assessment procedure and has earned the Conformité Européenne (CE) Mark.
Magellan Robotic system
The robotic system is useful in navigating to anatomical positions in the peripheral vasculature by creating a path for placing therapeutic devices. Since the system has the CE mark, Hansen would proceed to commercially deploy the Magellan system in Europe. Hansen would be deploying the robotic system in phases, first targeting select centres; the full launch is expected to be around the first half of 2012.
Professor Nicholas Cheshire is of the opinion that the new robotic system would prove to be extremely useful for doctors while conducting peripheral intervention procedures. He is the M.D of St.Mary’s Hospital in London and an expert in the usage of robotic tools for vascular interventions. He explained that the system is equipped with 3D robotic control which enables efficient routing of the catheter tips through a variety of anatomies and lesions. The patients are not exposed to any radiation throughout the procedure. Prof Cheshire added that by using the robotic system in conducting vitro and vivo animal studies the procedures are quickly completed and the interventions are much more predictable. He concluded by saying that endovascular interventions are also possible using the system, which opens up new options for treating patients.
The CEO of Hansen, Bruce J Barclay, regarded receiving the CE mark as proof of the technical efficiency and safety of the Magellan System and credited the development team at Hansen for the achievement. The Magellan System is compatible with the NorthStar Robotic catheter and other accessories associated with the catheter. Hansen is awaiting approval from the US Food and Drug Administration in order to proceed with the sale in the US. The Magellan System has aided more than 6,000 cardiac arrhythmia procedures, so far. Some of the other features of the system are robotic sheath stabilization, catheter and guide wire can be manipulated remotely, catheter can be monitored with the robot thus, causing less damage to animal arteries and is able to fit into operating rooms and labs without requiring much modification.