SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

November 03, 2014 16:05 ET

Hansen Medical Receives CE Mark for Magellan™ 6Fr Robotic Catheter

MOUNTAIN VIEW, CA--(Marketwired - Nov 3, 2014) - Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced the Company's Magellan™ 6Fr Robotic Catheter has received European Conformity (CE) Marking for use in the peripheral vasculature. Achieving this milestone allows the Company to market the Magellan 6Fr Robotic Catheter in Europe and other countries that require the CE Mark.

The 6Fr Robotic Catheter's new dual-bend technology enables independent robotic control of two separate bend sites on a single catheter, providing for precise robotic navigation and control. The small 6Fr outer diameter enables use of the Magellan Robotic System in smaller vessels in the peripheral vasculature and broadens use of intravascular robotics technology to physicians who may prefer a smaller diameter vessel insertion site.

"This is a significant milestone in the development of intravascular robotics," said Mo Hamady, M.D., Imperial College London. "Robotic catheters have the potential to provide physicians with enhanced control and navigation, especially in tortuous vessels. With this smaller-diameter robotic catheter, we can now broaden the types of procedures we are able to perform with the Magellan Robotic System. The new 6Fr Robotic Catheter increases the clinical applications to many interventional vascular therapies involving smaller vessels, including cancer treatment, women's health, and lower limb treatment."

The Magellan Robotic System is an advanced technology that drives the Magellan Robotic Catheters during endovascular procedures. Magellan is designed to offer procedural predictability, control, and catheter stability to physicians as they remotely navigate the robotic catheter through the vasculature. Magellan's remote workstation allows physicians to navigate through the vasculature while seated away from the radiation field, potentially reducing physicians' radiation exposure and procedural fatigue.

The Magellan 6Fr Robotic Catheter received FDA 510(k) clearance earlier this year and is commercially available in the U.S.

"The Company is excited to introduce the Magellan 6Fr Robotic Catheter to European physicians and their patients," said Cary Vance, Hansen Medical President and Chief Executive Officer. "With the increased clinical applications from the 6Fr catheter, more physicians can benefit from robotic precision and control in peripheral vascular procedures, and we can further ensure that hospitals investing in a Magellan intravascular robotics program can utilize our systems in the broadest possible way."

About the Magellan™ Robotic System
Hansen Medical's Magellan Robotic System is intended to be used to facilitate navigation in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic System is designed to deliver predictability, control and catheter stability to 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 U.S. and Europe. The Magellan Robotic System offers several important features including:

  • Provides predictability, control and catheter stability as a physician navigates a patient's peripheral vasculature and then provides a conduit for manual treatment of vascular disease with standard therapeutic devices.
  • Is designed to enable more predictable procedure times and increased case throughput potentially allowing hospitals to improve utilization within their vascular business line.
  • Employs an open architecture designed to allow for the subsequent use of many therapeutic devices on the market today.
  • Is designed to potentially reduce physician radiation exposure and fatigue by allowing the physician to navigate procedures while seated comfortably at a remote workstation away from the radiation field and without wearing heavy lead as required in conventional endovascular procedures.
  • The Magellan 9Fr Robotic Catheter allows for independent, robotic control of the distal tip of two telescoping catheters (an outer Guide and an inner Leader catheter), as well as robotic manipulation of standard guidewires.
  • The Magellan 6Fr Robotic Catheter allows for independent robotic control of two separate bend sites on a single catheter, as well as robotic manipulation of standard guidewires. This smaller catheter design may be preferred by certain physicians who prefer a smaller diameter vessel access site, or in procedures in smaller vessels.

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, Magellan™ 6Fr Robotic Catheter, and related accessories are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Company's mission is to enable Cardiac Arrhythmia and Endovascular Procedures and to improve patient outcomes through the use of Intravascular Robotics. Additional information can be found at www.hansenmedical.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 other 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 regarding the potential benefits of our robotic systems for hospitals, patients and physicians. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: factors relating to 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 rate of adoption of our systems and the rate of use of our catheters; our ability to manage expenses and cash flow, and obtain adequate financing; and other risks more fully described in the "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2013, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. 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.

"Artisan Extend," "Hansen Medical," "Hansen Medical (with Heart Design)," "Heart Design (Logo)," "Sensei," "Lynx," "Artisan," "Instinctive Motion," "Fine Force Technology," "IntelliSense" are registered trademarks, and "Magellan" and "Hansen Medical Magellan" are trademarks of Hansen Medical, Inc. in the U.S. and other countries.