MOUNTAIN VIEW, CA — (Marketwire) — 11/11/11 — Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible catheter robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced the world-s first uses of the Magellan Robotic System in the treatment of Peripheral Vascular Disease (PVD). The clinical procedures were performed by Professor Nick Cheshire, M.D. and the medical team at St. Mary-s Hospital, part of the Imperial College Healthcare in London, pioneers in the use of flexible robotics in vascular interventions.
The Magellan Robotic System is a new robotic approach in the treatment of vascular disease, and it has the potential to transform the way endovascular treatments are performed for patients with PVD. The System allows precise catheter navigation of peripheral vessels with a proprietary technology that enables independent distal tip control of a catheter and a sheath, as well as robotic manipulation of a standard guidewire from a centralized, remote workstation. The System was designed to allow precise and predictable catheter navigation of peripheral vessels while reducing procedure time, lessening radiation exposure, lowering procedural fatigue and enabling new procedures.
“Hansen Medical-s new Magellan Robotic System opens up the possibility for physicians to offer less invasive endovascular options to a broader group of patients suffering from complex disease,” said Professor Nick Cheshire, Head of Circulation Sciences at Imperial College Healthcare. “Imperial College has been pioneering the use of flexible robotics in vascular interventions, and the Magellan Robotic System now gives us access to the latest robotic catheter technology that is specifically designed for peripheral vascular interventions.”
“The first patients treated using the Magellan Robotic System is an important milestone in expanding the minimally invasive treatment options for patients with endovascular disease,” said Bert van Meurs, SVP Interventional X-ray of Philips Healthcare, which helped fund the development of the Magellan System. “Magellan demonstrates our commitment towards technological innovation and advancement in this field.”
“Today-s announcement is a significant milestone in the history of Hansen Medical. It reinforces our commitment to improve the lives of patients, and the physicians that treat and care for them, around the world, and opens up an entirely new market for the use of flexible robotics in the vasculature,” said Hansen Medical-s Bruce Barclay, president and CEO. “St. Mary-s is pioneering the use of flexible robotics in vascular interventions, and this is a tremendous opportunity to raise the profile of the Magellan System by generating physician experience and further developing clinical evidence in advance of a full scale commercial launch.”
Peripheral vascular disease refers to a cluster of conditions in which narrowing and hardening of blood vessels occurs in the peripheral circulation, particularly in the legs. It affects more than 27 million patients worldwide and approximately 500,000 patients undergo treatment each year in the EU. The rates of diabetes, hypertension, atherosclerosis, and obesity are also on the rise in the UK and worldwide and are contributors to the growth rate of vascular disease in an aging population.
Hansen Medical-s Magellan Robotic System is based upon the leading flexible robotic technology incorporated in the Sensei-X® Robotic Catheter System currently sold in the U.S. and Europe, which has been used in nearly 7,000 patients with cardiac arrhythmia, but includes a number of key enhancements. In particular, the Magellan Robotic System:
Allows for complete, 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 better access hard to reach peripheral anatomy.
Preserves the open architecture featured in the Sensei System to allow for the subsequent use with most 6F therapeutic devices on the market today.
Employs a catheter that is expected to be available in multiple lengths and has a low profile with significant flexibility to be compatible with most 6F treatment catheters currently used today.
Last year, the Company announced the completion of its First-in-Man study in Europe during which 20 endovascular procedures were successfully performed with an earlier version of the Magellan Robotic System, demonstrating its potential to allow physicians to effectively treat peripheral vascular disease, while lessening radiation exposure.
In Europe, the Magellan Robotic System and NorthStar Robotic Catheter are CE marked. In the U.S., the Magellan Robotic System requires U.S. Food & Drug Administration (FDA) clearance, and a 510(k) application is currently pending. As such, the products are not commercially available in the U.S.
Hansen Medical, Inc., based in Mountain View, California, develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. 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 electrophysiology (EP) procedures. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. 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 atrial fibrillation (AF), have not been established. In the European Union, the Sensei X System and Artisan Control Catheter are cleared for use during EP procedures, such as guiding catheters in the treatment of AF, and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. 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 conformity assessment and CE marking and are commercially available in the European Union. In the U.S., the Magellan Robotic System, the NorthStar Robotic Catheter and accessories are the subject of a current filing with the FDA and are not commercially available. Additional information can be found 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,” 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 timing of FDA clearance of our vascular robotic system in the US, the timing of first cases to be performed with the Magellan System, the potential benefits of our vascular robotic system on the vascular procedures and the timing of commercializing our vascular robotic system. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: engineering, regulatory and sales challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the uncertain timelines, costs and results of pre-clinical and clinical trials; 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; the effect of credit, financial and economic conditions on capital spending by our potential customers; our ability to manage expenses 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 September 30, 2011 filed with the SEC on November 7, 2011 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), and Sensei are registered trademarks of Hansen Medical, Inc. in the United States and other countries.
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
650.404.5800
Sharrifah Al-Salem, CFA
415.293.4414
John Capodanno
212.850.5705
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