SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

January 22, 2015 09:00 ET

Hansen Medical Announces Completion of World's First Intravascular Robot-Assisted IVC Filter Retrieval

MOUNTAIN VIEW, CA--(Marketwired - Jan 22, 2015) - Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced the completion of the world's first intravascular robot-assisted retrieval of an Inferior Vena Cava (IVC) Filter. Dr. Alan Lumsden, Vascular Surgeon and Director of the Methodist DeBakey Heart & Vascular Center, performed the procedure at Houston Methodist Hospital in Houston, Texas using the Magellan™ Robotic System to remove a filter manufactured by Cook® Medical.

"We are pleased to report the success of this initial procedure," said Dr. Lumsden. "This is another great example of how the precision, stability and control of the Magellan robotic catheters are being applied to help improve the predictability of many of the complex endovascular procedures that we perform on a daily basis."

An IVC filter is implanted in the inferior vena cava (the large vein that carries blood from the lower part of the body to the heart) to trap blood clots. IVC filters are placed in patients with contraindications to systemic anticoagulation who are at high risk for Deep Vein Thrombosis (DVT). DVT is a blood clot formed in the veins of the legs or pelvis that can have life-threatening consequences if it travels to the lungs, known as Pulmonary Embolism (PE). Estimates of the incidence of nonfatal PE range from 400,000 to 630,000 cases per year in the US, and 50,000 to 200,000 fatalities per year are directly attributable to PE1. It is estimated that more than 250,000 IVC filters are placed annually in the United States.2

Retrievable IVC filters can be removed from the body when the risk of PE has subsided or when the patient is able to tolerate blood thinning medications. The filter is retrieved via an endovascular procedure in which a hook on the filter is "snared" by a specially designed wire and pulled back into a catheter, and then removed from the body. Retrieval may be technically challenging or fail when a filter has tilted inside the body. By enabling a physician to change the angle and direction of the robotic catheter inside the blood vessel, Magellan may help a physician to more precisely target the hook of a tilted filter. 

"We would like to extend our congratulations to Dr. Lumsden and his team at Houston Methodist for continuing to identify promising new applications for the Magellan Robotic System in the treatment of vascular disease," said Cary Vance, President and Chief Executive Officer of Hansen Medical. "We are hopeful that as more experience is gained, intravascular robot-assisted IVC filter retrieval with Magellan can help a large number of patients benefit from a more predictable procedure."

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.

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 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 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 www.hansenmedical.com.

"Artisan Extend," "Hansen Medical," "Hansen Medical (with Heart Design)," "Heart Design (Logo)," "Sensei," "Artisan," "Instinctive Motion," "Fine Force Technology," "IntelliSense" are registered trademarks, and "Magellan" and "Hansen Medical Magellan" are trademarks of Hansen Medical, Inc. in the U.S. and other countries.

1 ACR-SIR Practice Parameters for the Performance of Inferior Vena Cava (IVC) Filter Placement for the Prevention of Pulmonary Embolism, Amended 2014.
2 Advanced IVC Filter Retrieval Techniques, Endovascular Today, November 2012
Options when risks of permanent device implantation outweigh the potential complications of retrieval.
Brian G. DeRubertis, MD