Corindus Vascular Robotics Announces Corindus Conditional Approval for Pivotal Study to Evaluate Robotic-Assisted Placement of Coronary Guidewires and Stent/Balloon Catheters
Published: Jan 26, 2011
NATICK, Mass.--(BUSINESS WIRE)--Corindus Vascular Robotics, a leading developer of precision vascular robotics, today announced it has been granted Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to evaluate the safety and effectiveness of its CorPath® 200 System in delivering and manipulating coronary guidewires and stent/balloon systems in percutaneous coronary interventions (PCI) procedures. With this approval, Corindus is authorized to begin its pivotal trial, CorPath PRECISE. The trial is a prospective, single-arm, multi-center, study, which will initially enroll 154 patients.