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First US Robotic Prostatic Artery Embolization Procedure Performed using Magellan Robotic System

Hansen Medical, Inc., 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.

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 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.



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