FDA Clears Hansen Medical's Magellan Robotic Catheter eKit

February 2, 2016—Hansen Medical, Inc. announced it has received US Food and Drug Administration clearance for the Magellan robotic catheter eKit (MRC eKit), which extends robotic capabilities and control throughout procedures in the peripheral vasculature. The MRC eKit provides physicians with robotic control of third-party microcatheters through the existing Magellan robotic catheter 6-F architecture with dual-bend technology. This added ability has the potential to help reduce procedure times and radiation exposure, stated Hansen Medical.

According to company, the MRC eKit is intended to be used with the Magellan robotic system and accessories. The Magellan robotic system facilitates navigation to anatomical targets in the peripheral vasculature and subsequently provides a conduit for manual placement of therapeutic devices. It is designed to deliver predictability, control, and catheter stability to endovascular procedures.

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

In the company’s press release, Ripal Gandhi, MD, of Miami Cardiac & Vascular Institute in Miami, Florida, commented, “The new Magellan robotic catheter eKit is a big step forward for our robotic vascular procedures. 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.”