Cardiac cath lab technology developer Corindus Vascular Robotics has received a U.S. Food and Drug Administration (FDA) conditional investigational device exemption (IDE) to evaluate the safety and effectiveness of its CorPath 200 system.
In its CorPath Percutaneous Robotically Enhance Coronary Intervention Study (PRECISE) trial, the Natick, MA-based vendor will evaluate the system for robotic-assisted placement of coronary guidewires and stent/balloon systems in percutaneous coronary interventions (PCI) procedures. The prospective, single-arm, multicenter study will initially enroll 154 patients, Corindus said.
The results of the study will serve as the basis for a 510(k) application to the FDA, Corindus said.
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