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Corindus wins FDA conditional approval for CorPath PRECISE study

Corindus Vascular Robotics has received US Food and Drug Administration (FDA) conditional investigational device exemption (IDE) approval for CorPath PRECISE trial, to evaluate the safety and effectiveness of its CorPath 200 System.

The trial is a prospective, single-arm, multi-center, study, which will initially enroll 154 patients and evaluates the system’s effectiveness in delivering and manipulating coronary guidewires and stent/balloon systems in percutaneous coronary interventions (PCI) procedures.

The CorPath 200 System allows for controlled robotic-assisted placement of coronary guidewires and stent/balloon catheters from an ergonomically optimized interventional cockpit, which protects the operator from radiation exposure.

The clinical endpoint of the trial is the ability to treat the patient without the incidence of major adverse cardiovascular events (MACE).

Corindus president and CEO David Handler said the CorPath System has the potential to raise the standard of care in PCI by cost effectively improving procedure results, while ultimately extending the physician’s capability, and career.