EU Certifies Compatibility of Hansen Medical's Magellan Robotic System and Philips' Allura Live Image-Guided System

July 17, 2013—Hansen Medical, Inc. (Mountain View, CA) and Royal Philips Electronics, Inc. (Andover, MA) announced European certification of compatibility of Hansen's Magellan robotic system with Philips' Allura live image-guidance systems for peripheral vascular interventions, when used according to instructions.

As part of the companies' long-term collaboration related to the Magellan robotic system and Philips' Allura interventional x-ray systems, compatibility is certified under article 12 of the European Union Medical Device Directive 93/42/EEC, as amended by 2007/47/EC, which covers specific technical and service requirements.

Philips began collaborating with Hansen Medical on the development of the Magellan robotic system in 2010. Hansen Medical subsequently received CE Mark approval for the system in 2011 and 510(k) clearance from the US Food and Drug Administration in 2012.

According to Hansen Medical, the Magellan robotic system is designed to navigate peripheral vessels. Magellan's robotic catheter technology provides stability and distal tip control of a catheter and sheath, as well as robotic control of standard guidewires. When using the Magellan system, the physician is seated away from the radiation source and can perform key elements of the procedure while seated comfortably in a centralized, remote workstation. The Magellan system is based upon the flexible robotic technology incorporated in the company's Sensei-X robotic catheter system, which is available in the United States and Europe.

Philips' product portfolio includes hybrid operating room solutions and live-imaging solutions, plus advanced navigation and interventional tools that work with them. The company has multiyear development programs and collaborations with other companies to improve existing minimally invasive procedures and enable new ones.

On July 3, Philips Electronics announced that it has received 510(k) clearance from the US Food and Drug Administration to market the AlluraClarity live-image guidance system in the United States. The AlluraClarity was commercially introduced outside the United States in 2012.