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Study Finds Magellan(TM) Robotic System From Hansen Medical Reduces Radiation to Operator by Over 80% in Transarterial Chemoembolization (TACE) Procedures

MOUNTAIN VIEW, CA--(Marketwired - Feb 3, 2015) - Hansen Medical, Inc. ( NASDAQ : HNSN ) -- An abstract accepted for presentation at the 40th Annual Society of Interventional Radiology (SIR) Meeting (February 28 - March 5, 2015, Atlanta, GA), found the use of the Magellan™ Robotic System in transarterial chemoembolization (TACE) procedures is feasible, and that remote robotic catheter navigation with Magellan leads to over 80% reduction in radiation dose to the operating physician when compared with a bedside control. Lead investigator Dr. Sandeep Rao, MD, MBA authored the abstract, which reviewed the results of seven patients treated with robot-assisted TACE using the Magellan 6Fr Robotic Catheter over a 5 month period at Sierra Medical Center in El Paso, Texas.

Technical success of TACE with drug eluting beads was 100%. No major or access site complications were encountered. Average radiation exposure to the operator, as measured by RaySafe radiation monitoring, was reduced by over 80% using remote, robotic catheter navigation with Magellan when compared with the control site at the patient's bedside. Dr. Rao concluded that "The Magellan Robotic System is safe and feasible for routine use in transarterial chemoembolization." Dr. Rao will present his findings on Monday, March 2, 2015 at 5:10pm during the "Emerging Concepts" session at SIR 2015. 

"Radiation exposure during complex embolization procedures is a serious occupational hazard for interventionalists, and physician societies such as SIR are increasingly focusing on efforts to educate their members and reduce exposure," said Cary Vance, President and CEO of Hansen Medical. "We applaud the work done by Dr. Rao to demonstrate the potential benefits of Magellan in TACE, which is the most common embolization procedure performed by Interventional Radiologists worldwide."

TACE is a minimally-invasive procedure involving catheter-based delivery of small embolic materials into selected, small arteries to deliver targeted chemotherapy and cut off the blood supply feeding a tumor in the liver. Approximately 175,000 TACE procedures are performed worldwide each year.1 TACE is most often performed in patients with Hepatocellular Carcinoma (HCC), which is the 5th most common cancer and the 3rd leading cause of cancer deaths in the US. The expected radiation dose rate to the operator in TACE procedures is approximately 4x higher than that in cardiac intervention, due to the larger imaging field size.2 Interventional Radiologists at several centers in the US and Europe are performing TACE procedures with the Magellan Robotic System.

"This study provides an excellent foundation for use of intravascular robotics in TACE procedures," said Dr. Rao, an Interventional Radiologist with Sierra Providence Health Network. "Robotic catheters have the potential to provide physicians with enhanced control in tortuous blood vessels; and the stability of the Magellan Robotic Catheter can help to ensure precise and targeted delivery of embolic materials, which is a critical part of these procedures."

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 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, 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.

1 US Markets for Transcatheter Embolization and Occlusion Devices 2014, European Markets for Transcatheter Embolization and Occlusion Devices 2014, Japanese Markets for Transcatheter Embolization and Occlusion Devices 2013, Millennium Research Group Reports
2 FluoroSafety.com