Hansen Gets FDA Clearance for CoHesion Module

The FDA has granted 510(k) clearance to Hansen Medical for its CoHesion 3-D visualization module for use in complex electrophysiology mapping procedures.

The module allows physicians to see the 3-D location of catheters inside a heart, Hansen said.

The product uses an integrated software interface between the company’s Sensei robotic catheter system and the EnSite System advanced mapping software from St. Jude Medical.