Hansen Medical, Inc., a global leader in intravascular robotics, and Royal Philips today announced that they have reached an important milestone in their long-term collaboration by securing certified compatibility -- article 12 of the Medical Device Directive 93/42/EEC, as amended by 2007/47/EC -- between Hansen Medical's Magellan™ Robotic System and Philips' Allura interventional X-ray systems.
Article 12 compatibility covers specific technical and service requirements, and means that the Magellan Robotic System is compatible with Philips' Allura live image-guidance systems when used according to instructions.
The Magellan Robotic System uses advanced technology to navigate peripheral vessels. The Magellan System's proprietary robotic catheter technology is designed to deliver 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.
Philips began collaborating with Hansen Medical on the development of the Magellan Robotic System in 2010. Hansen Medical subsequently received CE-marking for the system in 2011 and 510(k) clearance from the US Food and Drug Administration (FDA) in mid-2012.
"We are pleased to secure this important certification with Philips, our longstanding imaging partner for our robotic systems," said Bruce Barclay, President and CEO of Hansen Medical. "Article 12 compatibility ensures seamless coordination and integration of the Magellan Robotic System with Philips' most advanced live-image guidance systems for our hospital and physician customers, enabling greater access to innovative solutions."
As a leader in image-guided interventions and therapies, Philips offers a comprehensive portfolio that includes hybrid operating room solutions and live-imaging solutions, plus advanced navigation and interventional tools that work seamlessly with them. The company has multi-year development programs and collaborations with leading innovators to improve existing minimally-invasive procedures and enable new ones.
"In addition to improving patient outcomes, Philips is committed to reducing the cost and increasing the speed and safety of image-guided interventions and therapies through collaboration and meaningful innovation," said Bert van Meurs, Senior Vice President, General Manager Integrated Clinical Solutions & Marketing at Imaging Systems, Philips Healthcare. "We believe that robotic-assisted interventional techniques have great potential, which is why we have been collaborating with Hansen Medical for many years now. We continue to strive for seamless integration of our own and our partners' innovations to deliver meaningful clinical solutions for our customers."
About the Magellan™ Robotic System
Hansen Medical's Magellan Robotic System is based upon the flexible robotic technology incorporated in the Sensei-X® Robotic Catheter System currently sold in the U.S. and Europe, which has been used in over 10,000 patients, but includes a number of key enhancements. In particular, the Magellan Robotic System:
- Provides solid catheter stability for placement of therapeutic devices.
- Is designed to enable predictable procedure times and increased case throughput.
- Allows for independent, individual robotic control of the distal tips of both the outer sheath and the inner leader catheter, as well as robotic manipulation of standard guidewires.
- Is designed to allow for sufficient extension inside the body to access hard to reach peripheral anatomy.
- Preserves the open architecture featured in the Sensei System to allow for the subsequent use of many 6F therapeutic devices on the market today.
- Is designed to potentially reduce physician radiation exposure and fatigue by employing a remote physician workstation.