Hansen Medical, Inc. (HNSN)

[crudeoil24]

Hansen Medical(R) Announces FDA Clearance of the Magellan(TM) Robotic Catheter eKit
1 hour 8 minutes ago - DJNF

Hansen Medical(R) Announces FDA Clearance of the Magellan(TM) Robotic Catheter eKit
MOUNTAIN VIEW, CA--(Marketwired - Feb 2, 2016) - Hansen Medical(R), Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Magellan(TM) 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.

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.

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, MD of Miami Cardiac & Vascular Institute (MCVI) in Miami, FL. "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."