SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

November 04, 2015 08:00 ET

Hansen Medical Announces World's First Clinical Cases With New Magellan™ Robotic Microcatheter Driver

First Clinical Case Performed at Hopital Europeen Georges Pompidou (HEGP-APHP)

MOUNTAIN VIEW, CA--(Marketwired - Nov 4, 2015) - Hansen Medical, Inc. (NASDAQ: HNSN), announced today the completion of the world's first clinical procedure using the Magellan™ Robotic Microcatheter Driver as part of the clinical study: Embolization Procedures in Peripheral Vasculature. Study Principal Investigator, Professor Marc Sapoval, MD, MSc and Dr. Gregory Amouyal, MD performed the procedure at Hôpital Européen Georges Pompidou (HEGP-APHP). The study case was a prostate artery embolization (PAE) procedure for the treatment of benign prostatic hyperplasia (BPH).

The Magellan Robotic Microcatheter Driver is the latest design the company is seeking to add to the growing family of approved devices. The Magellan Microcatheter Driver's design provides for robotic navigation and control of a wide variety of 3rd party microcatheters and expands the application of the Magellan Robotic System to a greater portion of many endovascular procedures.

"We are pleased to complete the world's first clinical procedure using the Magellan Microcatheter Driver as part of this clinical study," explained Professor Sapoval. "Manual control of microcatheters and microwires can be challenging, particularly in tortuous anatomy. By utilizing the Microcatheter Driver in conjunction with the Magellan 6Fr Robotic Catheter, we are enhancing the utility of the Magellan Robotic System and realizing its potential in a pivotal aspect of embolization procedures. "

"Today's announcement is an important milestone for Hansen Medical. Upon regulatory approval, the Magellan Robotic Microcatheter Driver will be an important expansion of our product line and represents a step forward in our goal toward vascular interventions that will eventually be performed 100% robotically," said Cary Vance, President & CEO of Hansen Medical. "By advancing microcatheters with the Magellan System, we expect to add greater precision while continuing to provide physicians the benefit of reduced exposure to procedural radiation. We are pleased to partner with HEGP-APHP as part of our shared commitment to improve the care of patients through the application of advanced technologies."

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 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 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 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.