MOUNTAIN VIEW, CA--(Marketwired - Feb 2, 2016) - Hansen Medical®, Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Magellan™ Robotic Catheter eKit (MRC eKit). The MRC eKit is the company's latest addition to the family of approved Magellan Robotic Catheters and helps extend robotic capabilities and control throughout procedures in the peripheral vasculature. With the MRC eKit, physicians will now have robotic control of 3rd party microcatheters through the existing Magellan Robotic Catheter 6Fr architecture. This added ability has the potential to help reduce procedure times and radiation exposure.
This approval comes after multiple cases were performed with the MRC eKit by Professor Marc Sapoval, MD, MSc at Hôpital Européen Georges Pompidou (HEGP-APHP) in Paris, France as a part of the Embolization Procedures in Peripheral Vasculature clinical study. Professor Sapoval successfully performed several prostate artery embolization (PAE) procedures and uterine artery embolization (UFE) procedures with the MRC eKit as a part of this study.
With FDA approval, the MRC eKit will now be used by physicians in the United States. "The new Magellan Robotic Catheter eKit is a big step forward for our robotic vascular procedures," said Ripal Gandhi, MD of Miami Cardiac & Vascular Institute (MCVI) in Miami, FL. "With the added robotic capabilities, we will be able to work outside of the radiation zone throughout more of the procedure and will be able to extend the stability and precision of robotic technology to the smaller microcatheters during our procedures."
"We are proud to continue to offer advances in our portfolio of robotic catheters," said Cary Vance, Chief Executive Officer of Hansen Medical. "We have seen strong robotic procedure growth, particularly in men's health, women's health and cancer treatment, since the introduction of the Magellan Robotic Catheter 6Fr, and we expect that the development of the Magellan Robotic Catheter eKit will continue to expand our presence within the Interventional Radiology space. We have placed a heavy focus on advancing our Magellan technology to enable robotic control of smaller catheters and look forward to the benefits that these added robotic capabilities will offer to patients and physicians."
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.
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 Catheter eKit provides robotic control of 3rd party microcatheters through a robotic catheter with dual-bend technology. It 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 and is intended to be used with the Hansen Medical Magellan Robotic System and accessories.
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.
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.