MOUNTAIN VIEW, CA — (Marketwired) — 09/28/15 — Hansen Medical, Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today announced the completion of the first robot-assisted Prostatic Artery Embolization (PAE) procedure in the United Kingdom with the Magellan Robotic System. Interventional Radiologist Dr. Mohammad Hamady performed the procedure at St. Mary–s Hospital, Imperial College in London. Dr. Hamady used the Magellan 6Fr Robotic Catheter for navigation in the peripheral blood vessels during the PAE procedure for the treatment of Benign Prostatic Hyperplasia (BPH).
“I am extremely pleased by the outcome of this initial procedure and I am excited to be able to offer this promising new treatment for a condition affecting a large number of patients,” said Dr. Hamady. “Robotic catheters offer precise control, even in these narrow and often tortuous blood vessels, which enables us to confidently offer this non-surgical option to help men suffering from the effects of prostate enlargement.”
BPH is a common condition affecting more than 50% of men over age 50. If left untreated, BPH can lead to complications including a weakened bladder, bladder stones or infections and a diminished quality of life, as sleep is often interrupted by a frequent need to urinate during the night. Prostatic Artery Embolization (PAE) is a novel therapy in which the prostate size is reduced and symptoms are relieved by a non-surgical, catheter-based approach that reduces blood flow to the main arteries feeding the prostate. PAE is an alternative to long-term medical therapy or invasive surgical options that may result in complications such as pain, bleeding, incontinence or impotence.
The Magellan Robotic System is an advanced technology that drives the Magellan Robotic Catheters during minimally-invasive, endovascular procedures. Magellan is designed to offer procedural predictability, control and catheter stability to physicians as they remotely navigate the robotic catheter through peripheral blood vessels. Physicians worldwide use Magellan to control catheters in procedures for the treatment of conditions, including BPH, uterine fibroids, cancer and vascular disease.
“Congratulations to Dr. Hamady and the team at St. Mary–s Hospital and Imperial College London,” said Cary Vance, President and Chief Executive Officer of Hansen Medical. “The team at Imperial College have done groundbreaking work, pioneering the use of robotics for endovascular procedures performed in the peripheral vasculature. We are excited that patients in the UK suffering from BPH may now benefit from a non-surgical treatment option with the enhanced precision and predictability offered by 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.
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 .
“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.
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