The FDA has granted Corindus Vascular Robotics' investigational device exemption (IDE) approval, which will evaluate the CorPath 200 system, a delivery system for guidewires and stent and balloon systems, during the PRECISE clinical trial.
The PRECISE (Percutaneous Robotic-Enhanced Coronary Intervention Study) trial is a prospective, single-arm, multicenter trial that will enroll 154 patients and evaluate the radiation exposure of the interventional cardiologist when the CorPath technology is used compared to when the procedure is done at the table during PCI procedures. The study’s primary endpoint is major adverse cardiovascular events rates.
With use of the CorPath 200 system, a physician performs the procedure via a single-use cassette that is mounted off of an articulating arm attached to the cath lab table and behind a shield.
The Natick, Mass.-based company said that it expects the first procedures of the trial to be conducted early this year. The first human clinical trial evaluating the CorPath 200 System was completed in March 2010.