Hansen Medical® Reports FDA Clearance of the Magellan™ Robotic Catheter eKit

Hansen Medical®, Inc. (NASDAQ:HNSN) has received US 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 3^rd party microcatheters through the existing Magellan Robotic Catheter 6Fr architecture. This added ability has the potential to help reduce procedure times and radiation exposure.
According to the company’s press release:

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

Cary Vance, Chief Executive Officer of Hansen Medical commented:

We are proud to continue to offer advances in our portfolio of robotic catheters.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 6Fr, 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.

Click here to view the full press release.