MOUNTAIN VIEW, CA, and ANDOVER, MA — (Marketwired) — 07/17/13 — 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 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.”
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.
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 .
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 .
This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “plan,” “expects,” “potential,” “believes,” “goal,” “estimate,” “anticipates,” and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include statements about the potential benefits of our Magellan Robotic System for hospitals, patients and physicians, and the anticipated timing of commercially launching a 6F vascular catheter. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: engineering, regulatory, manufacturing, sales and customer service challenges in developing new products and entering new markets; the commercial viability of our products in the vascular markets; potential safety and regulatory issues that could slow or suspend our sales; the effect of economic conditions on capital spending by our potential customers; the uncertain timelines for the sales cycle for newly introduced products; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; our ability to manage expenses and cash flow, and obtain additional financing; and other risks more fully described in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 filed with the SEC on May 10, 2013 and the risks discussed in our other reports filed with the SEC. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart Design), Sensei and Lynx are registered trademarks, and Magellan is a trademark of Hansen Medical, Inc. in the United States and other countries.
Investor Contacts:
Peter J. Mariani
Chief Financial Officer Hansen Medical Inc.
Tel: +1 650.404.5800
Brian Ritchie
FTI Consulting, Inc.
Tel: +1 212.850.5683
E-mail:
John Capodanno
FTI Consulting, Inc.
Tel: +1 212.850.5705
E-mail:
Rachel Bloom-Baglin
Philips Healthcare
Tel: +1 978 7609007
E-mail:
Steve Klink
Philips Corporate Communications
Tel.: +31 6 10888824
E-mail:
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