MOUNTAIN VIEW, CA — (Marketwired) — 10/21/14 — Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced the completion of the first robot-assisted Uterine Fibroid Embolization (UFE) in the United States. Sandeep Rao, MD, Interventional Radiologist, performed the procedure at Sierra Medical Center in El Paso, Texas using the Magellan Robotic System.
“I am extremely pleased by the outcome of this initial procedure,” said Dr. Rao. “Robotic catheters have the potential to provide enhanced control and precision, especially in the small, often tortuous blood vessels involved in UFE. The Magellan system enables us to offer a compelling, non-surgical, robotic treatment option for a condition affecting a large number of women.”
Uterine fibroids are non-cancerous tumors in or around the uterus, and are the most common benign tumors in women. Between 20 and 40% of women over the age of 20 will develop a symptomatic uterine fibroid before reaching menopause. Uterine fibroids are associated with symptoms including irregular and prolonged menstrual bleeding, pelvic pain or pressure, lower back pain, constipation, frequent urination or painful intercourse.
Uterine Fibroid Embolization is a proven, non-surgical procedure in which a catheter is used to deliver tiny particles to block the blood vessels supplying blood to the fibroids. When compared with more invasive alternative treatment options, UFE offers the potential for a shorter hospital stay, a faster recovery time, and keeping the uterus intact. Approximately 30,000 UFE procedures are performed in the United States annually. While robot-assisted UFE procedures have been performed in Europe with the Magellan system, this week–s procedure at Sierra Medical Center was the first in the United States.
The Magellan Robotic System offers physicians robotic catheter control and stability during complex procedures in the peripheral blood vessels, and is used by physicians worldwide in a wide variety of catheter-based procedures. With the recent FDA 510(k) clearance for the smaller diameter Magellan 6Fr Robotic Catheter, physicians are now able to perform robotic procedures in smaller blood vessels, including those accessed during a UFE procedure.
“Congratulations to Dr. Rao and the entire team at Sierra Medical Center on this exciting milestone,” said Cary Vance, President and CEO of Hansen Medical. “With the recent introduction of the new 6Fr Robotic Catheter, physicians and hospitals are now able to broaden their use of Magellan and apply the benefits of robotic control and precision to intravascular procedures in smaller blood vessels, including UFE.”
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 guidewires.
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 guidewires. This smaller catheter design may be preferred by certain physicians who prefer a smaller diameter vessel access site, or in procedures in smaller vessels.
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 .
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.
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