SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

July 01, 2015 16:30 ET

Hansen Medical® Announces FDA Clearance of the Magellan™ 10Fr Robotic Catheter

MOUNTAIN VIEW, CA--(Marketwired - Jul 1, 2015) -  Hansen Medical®, Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Magellan™ 10Fr Robotic Catheter for use in the peripheral vasculature. The FDA clearance enables the company to initiate clinical use of the 10Fr catheter with its customers in the United States.

The Magellan 10Fr Robotic Catheter is the latest addition to the family of robotic catheters used with the Magellan Robotic System. The 10Fr catheter allows for independent, robotic control of two telescoping catheters (an outer Guide and an inner Leader catheter). The Guide catheter has a 10Fr outer diameter, and features the largest inner lumen (7Fr) in the Magellan catheter family, which enables delivery of therapeutic devices through the robotic catheter in a broader range of endovascular procedures. The company received CE Mark approval for the 10Fr catheter in April 2015, and procedures have subsequently been performed with the device in Australia, Germany and the United Kingdom. 

"We have been eagerly anticipating having access to the Magellan 10Fr Robotic Catheter," said Dr. Fred Weaver, Chief of Vascular Surgery and Endovascular Therapy at Keck Hospital of the University of Southern California (USC). "Our team has found significant clinical value in the Magellan system to predictably navigate tortuous vascular anatomy and provide a stable platform during treatment. The 10Fr catheter, with its larger inner lumen, will enable us to broaden our use of Magellan to include many additional procedures in which the delivery of stents, balloons or other devices requires a 7Fr catheter inner lumen."

The Magellan Robotic System is an advanced technology that drives Magellan Robotic Catheters and guide wires during minimally-invasive, endovascular procedures. Magellan is designed to offer procedural predictability, precision, and catheter stability as physicians navigate inside blood vessels and deliver therapy. Image-guided medical procedures using interventional fluoroscopy, while growing rapidly, are the leading source of occupational ionizing radiation exposure for medical personnel1. Magellan's remote workstation allows physicians to control robotic catheters and guide wires while seated away from the radiation field, which has been shown to reduce radiation exposure for the physician by as much as 95% in complex endovascular procedures2.

"We are excited to introduce the Magellan 10Fr Robotic Catheter to our customers in the United States," said Cary Vance, President and Chief Executive Officer of Hansen Medical. "We believe that robotic technology offers the potential to transform how endovascular treatment is performed, by bringing enhanced control and predictability to procedures, and by addressing serious occupational hazards faced by physicians and their teams in the delivery of patient care. With this new catheter, we expect that many more patients will now be able to benefit from procedures with the Magellan Robotic System."

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 procedures globally. 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 and 10Fr Robotic Catheters allow for independent, robotic control of two telescoping catheters (an outer Guide and an inner Leader catheter), as well as robotic manipulation of standard guide wires.
  • 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 guide wires. 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, Magellan Robotic Catheters, 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.

"Hansen Medical," "Hansen Medical (with Heart Design)," and "Heart Design (Logo)" are registered trademarks, and "Magellan" and "Hansen Medical Magellan" are trademarks of Hansen Medical, Inc. in the U.S. and other countries. All other trademarks are the property of their respective owners.

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, 2014, 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.

1 U.S. Environmental Protection Agency of Radiation Protection Programs Home Page; Health Effects, http://www.epa.gov/rpdweb00/understand/health_effects.html (Accessed on November 10, 2014)

2 Robotic Catheter Assistance: The Relationship on Radiation Exposure, presentation by Barry Katzen, MD during Charing Cross International Symposium, London, April 29, 2015.