Hansen Medical and Philips reinforce collaboration in robotic systems for endovascular interventions
- Companies secure certified compatibility of Hansen Medical’s Magellan® Robotic System and Philips’ Allura interventional X-ray systems
- Magellan System is currently the only robotic system on the market intended for use in the peripheral vasculature
Mountain View, CA, Andover, MA – Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, and Royal Philips (NYSE: PHG, AEX: PHIA) 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 Robotic 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 Robotic 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 Royal Philips:
Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people’s lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2012 sales of EUR 24.8 billion and employs approximately 116,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at www.philips.com/newscenter.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is the global leader in intravascular robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company’s Magellan™ Robotic System, NorthStar™ Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone both CE marking and 510(k) clearance and are commercially available in the European Union, and the U.S. In the European Union, the Company’s Sensei® X Robotic Catheter System and Artisan Control Catheter are cleared for use during electrophysiology (EP) procedures, such as guiding catheters in the treatment of atrial fibrillation (AF), and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the U.S. the Company’s Sensei X Robotic Catheter System and Artisan Control Catheter were cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in EP procedures. In the United States, the Sensei System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that the safety and effectiveness of the Sensei X System and Artisan Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established. Additional information can be found at www.hansenmedical.com.
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