MOUNTAIN VIEW, CA — (Marketwire) — 10/13/11 — Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced it will exhibit its Magellan Robotic System at the Vascular InterVentional Advances (VIVA) conference, from October 18-21 at the Wynn in Las Vegas. The Company will be conducting product demonstrations and exhibiting the Magellan Robotic System at Booth 508.
Hansen Medical will also be exhibiting its NorthStar Robotic Catheter, designed to work with the Magellan Robotic System. The NorthStar Catheter is designed to simplify and enhance catheter navigation and therapeutic intervention through a variety of clinical cases in the peripheral vasculature, including challenging anatomy, diffuse disease and chronic total occlusions.
“We are excited to exhibit our Magellan Robotic System at this leading education course on peripheral vascular intervention,” said Bruce Barclay, president and CEO of Hansen Medical. “We believe the Magellan System, which features our proprietary flexible robotic technology with unique distal tip catheter control, has the potential to transform the way endovascular treatments are performed. The System was designed to assist physicians to safely, effectively and efficiently treat a variety of peripheral diseases, while reducing procedure time, lessening radiation exposure and enabling new procedures.”
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 more than 6,000 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, which is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, has undergone conformity assessment and CE marking and is commercially available in the European Union. The NorthStar Robotic Catheter and related accessories are also CE marked. 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. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “plan,” “potential,” “believes,” and similar words. Examples of such statements include statements about the potential benefits of our Magellan system in the treatment of patients with peripheral vascular disease, and statements about 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, potential safety and regulatory issues that could delay, suspend or terminate future clinical studies or regulatory approvals, challenges in designing, engineering and manufacturing systems to function as intended, uncertain timelines, costs and results of clinical trials, and the scope and validity of intellectual property rights applicable to products being developed. These and other risks are described in greater detail under the heading “Risk Factors” contained in our periodic SEC filings, including our Quarterly Report on Form 10-Q filed with the SEC on August 8, 2011. 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, and Artisan, Lynx, Magellan and NorthStar are 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
415-293-4414
John Capodanno
212-850-5705
You must be logged in to post a comment Login