First Patient Enrolled in Corindus' Postmarket PRECISION GRX Registry
September 12, 2017—Corindus Vascular Robotics, Inc. announced that the first patient was enrolled in the PRECISION GRX Registry, a postmarket study to continue surveillance of the company's second-generation CorPath GRX system. The procedure was performed by Srini Potluri, MD, at The Heart Hospital Baylor Plano in Plano, Texas. The PRECISION GRX Registry will enroll up to 1,000 patients receiving robotic-assisted percutaneous coronary intervention (PCI) at up to 25 sites.
According to the company, the registry will gather data to evaluate patient outcomes, potential economic benefits, procedural parameters, and the expanding capabilities of robotics in PCI. Additional substudies will seek to evaluate the impact of robotics on left transradial access and robotic wiring times. In October 2016, Corindus announced 510(k) clearance from the US Food and Drug Administration for the CorPath GRX. In February 2017, the company announced that the first commercial procedures were performed with the device.
Ehtisham Mahmud, MD, the Global Principal Investigator for the PRECISION GRX Registry, commented in the company's press release, "We have shown that robotic-assisted PCI can be used with high clinical and technical success in multiple sites with multiple operators and the new registry is designed to evaluate the impact of the expanding capabilities of robotics. I look forward to spearheading the effort in evaluating this new technology and its value in current practice."