MOUNTAIN VIEW, CA — (Marketwired) — 11/20/14 — Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced the completion of the first robotic prostatic artery embolization (PAE) in the United States. Dr. Sandeep Bagla, interventional radiologist, performed the procedure at Inova Alexandria Hospital in Alexandria, Virginia using the Magellan Robotic System.
“This is a major step forward in delivering a less invasive procedure for the treatment of benign prostatic hyperplasia or BPH,” said Dr. Bagla. “The Magellan Robotic System has the potential to allow interventional radiologists achieve excellent catheter precision and control in this developing therapy. PAE is a growing and attractive non-surgical option for BPH, a condition affecting over 20 million men in the U.S. and the Magellan Robotic System could play an integral role in this procedure.”
BPH or enlargement of the prostate, is a common condition that affects over 50% of men aged 50 and as high as 80% of men aged 80 or older. The continued enlargement of the prostate gland can lead to difficulties associated with the bladder and urination. Sufferers of BPH may experience a diminished quality of life as sleep is often interrupted by a frequent need to urinate during the night. If untreated, BPH can lead to complications including a weakened bladder, blockage, bladder stones or infections.
PAE is a therapy in which the size of the prostate is reduced by a less invasive catheter-based approach that works to reduce blood flow to the main arteries that feed the prostate. Successfully performed, prostatic artery embolization can reduce the prostate gland size and eliminate the symptoms associated with BPH. Currently a patient must choose between long-term medical therapy or highly invasive surgical options that may often result in complications such as pain, bleeding, incontinence or impotence. Some sources have estimated that almost 2 million men did not seek therapy last year because of the potential complications that can result from a traditional surgical approach.
“We would like to extend our congratulations to Dr. Bagla and his team at Inova Alexandria for their groundbreaking work on robotic PAE,” said Joe Guido, Vice President of Marketing and Business Development at Hansen Medical. “We are excited about the application of the Magellan Robotic System to this exciting therapy and the potential impact on PAE procedures.”
The Magellan Robotic System is an advanced technology that drives the Magellan Robotic Catheters during endovascular procedures. Magellan is designed to offer procedural predictability, control, and catheter stability to physicians as they remotely navigate the robotic catheter through the vasculature. Magellan–s remote workstation allows physicians to navigate through the vasculature while seated away from the radiation field, potentially reducing physicians– radiation exposure and procedural fatigue.
The Magellan 6Fr Robotic Catheter received FDA 510(k) clearance earlier this year and is commercially available in the U.S.
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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