Hansen Medical Gets FDA Clearance for New Robotic Catheter eKit

Mountain View, Calif.-based Hansen Medical Inc., an intravascular robotics company, has received U.S. Food and Drug Administration (FDA) clearance for the Magellan Robotic Catheter eKit (MRC eKit). The MRC eKit is the company’s latest addition to the family of approved Magellan Robotic Catheters and helps extend robotic capabilities and control throughout procedures in the peripheral vasculature. With the MRC eKit, physicians will now have robotic control of third party microcatheters through the existing Magellan Robotic Catheter 6 Fr architecture. This added ability has the potential to help reduce procedure times and radiation exposure.

This approval comes after multiple cases were performed with the MRC eKit by Professor Marc Sapoval, M.D., M.Sc. at Hôpital Européen Georges Pompidou (HEGP-APHP) in Paris, France as a part of the Embolization Procedures in Peripheral Vasculature clinical study. Sapoval successfully performed several prostate artery embolization procedures and uterine artery embolization procedures with the MRC eKit as a part of this study.

With FDA approval, the MRC eKit will now be used by physicians in the United States.

“The new Magellan Robotic Catheter eKit is a big step forward for our robotic vascular procedures,” said Ripal Gandhi, M.D., of Miami Cardiac & Vascular Institute in Miami, Fla. “With the added robotic capabilities, we will be able to work outside of the radiation zone throughout more of the procedure and will be able to extend the stability and precision of robotic technology to the smaller microcatheters during our procedures.”

“We are proud to continue to offer advances in our portfolio of robotic catheters,” said Cary Vance, CEO of Hansen Medical. “We have seen strong robotic procedure growth, particularly in men’s health, women’s health and cancer treatment, since the introduction of the Magellan Robotic Catheter 6 Fr, and we expect that the development of the Magellan Robotic Catheter eKit will continue to expand our presence within the Interventional Radiology space. We have placed a heavy focus on advancing our Magellan technology to enable robotic control of smaller catheters and look forward to the benefits that these added robotic capabilities will offer to patients and physicians.”

The Magellan Robotic System is an advanced technology that drives Magellan Robotic Catheters and guide wires during minimally-invasive, endovascular procedures. Magellan is designed to offer procedural predictability, precision, and catheter stability as physicians navigate inside blood vessels and deliver therapy. Image-guided medical procedures using interventional fluoroscopy, while growing rapidly, are the leading source of occupational ionizing radiation exposure for medical personnel. Magellan’s remote workstation allows physicians to control robotic catheters and guide wires while seated away from the radiation field, which has been shown to reduce radiation exposure for the physician by as much as 95 percent in complex endovascular procedures.