Hansen Medical(R) Announces Filing of 510K for Expanded Neurological Indication for Magellan(TM) Product Line
MOUNTAIN VIEW, CA--(Marketwired - Apr 26, 2016) - Hansen Medical®, Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today provides an update on the status of its key corporate initiative to expand the utility and regulatory labeling of the Magellan™ product line.
Hansen Medical recently submitted a 510k to the FDA for a neurological indication for the Magellan Robotic System. If successful, the Magellan Robotic System would be fully indicated for applications in peripheral vascular and neurological procedures.
"Our experience in performing robotically assisted carotid stent procedures has shown that there could be important advantages for neuro applications including many of the benefits we have seen in other applications, like embolization and other endovascular therapies," said Barry T. Katzen, MD of Miami Cardiac & Vascular Institute in Miami, FL.
"We anticipate that an added neurological indication would allow us to bring the benefits of robotics to a new specialty of physicians who could, in turn, offer robotic solutions to a new patient population," said Cary Vance, Hansen Medical's President and Chief Executive Officer. "We are excited by the potential to expand the procedure base in which robotics can play a role."
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.
The Magellan Robotic Catheter eKit provides robotic control of 3rd party microcatheters through a robotic catheter with dual-bend technology. This configuration may provide an additional level of robotic control during procedures in which therapy is delivered through a microcatheter.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is the 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 Hansen Medical's Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 and Hansen Medical's 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.
