|By Marketwired .||
|January 20, 2014 06:00 AM EST||
MOUNTAIN VIEW, CA -- (Marketwired) -- 01/20/14 -- Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in Intravascular Robotics, today announced that Dr. Barry Katzen, founder and Medical Director of Baptist Cardiac & Vascular Institute (Baptist Hospital of Miami), is scheduled to utilize the Magellan Robotic System in three live endovascular cases at the 26th Annual International Symposium on Endovascular Therapy (ISET), from January 18th - 22nd at the Fontainebleau Miami Beach Hotel in Miami, FL. The Company will also be exhibiting the Magellan Robotic System during the meeting at Booth 603.
Dr. Katzen, a course director at ISET, plans to utilize the Magellan Robotic System during one case scheduled for Monday, January 20th at 1:00 pm, and two additional cases on Tuesday, January 21st, at 8:00 am and 1:00 pm, respectively.
Additionally, Dr. Constantino Peña of Baptist Cardiac & Vascular Institute will deliver a Magellan themed presentation, titled "Robotics in Peripheral Intervention" during the "Nurses & Technologists Symposium: Innovations in Cardiac and Vascular Care" session on Saturday, January 18th at 11:00 am.
"We are pleased that Dr. Katzen will showcase the Magellan Robotic System at ISET, which is in its 26th year of bringing together interventional cardiologists, vascular surgeons and other healthcare professionals to focus on acquiring the latest knowledge and product information related to interventional medicine and vascular disease," said Bruce Barclay, president and CEO of Hansen Medical. "We continue to build a growing body of positive clinical data with the Magellan system, and live cases such as these provide Hansen Medical with the opportunity to highlight to the interventional vascular community how our technology can significantly enhance endovascular procedures."
About the Magellan Robotic System
Hansen Medical's Magellan Robotic System is intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic System is designed to deliver predictability to simple and complex endovascular procedures. Since its commercial introduction in the U.S. and Europe, the Magellan Robotic System has demonstrated its clinical versatility in many cases in a broad variety of peripheral vascular procedure types in centers across the US and Europe. The 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 13,000 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.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is a 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, 9Fr Magellan 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® and Artisan Extend® Control Catheters 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 and Artisan Extend Control Catheters are cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in EP procedures. In the U.S., the Sensei X Robotic Catheter 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 Robotic Catheter System and Artisan and Artisan Extend 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.
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 technology and the value of our intellectual property portfolio. 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; potential safety and regulatory issues that could slow or suspend our sales; the effect of credit, financial and 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 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 September 30, 2013 filed with the SEC on November 8, 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 and NorthStar are trademarks of Hansen Medical, Inc. in the United States and other countries.
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