Corindus Vascular Robotics announced the first patient enrollment in a post-market study of its second-generation CorPath GRX System, a robot-assisted system for percutaneous coronary interventions such as stenting.
“Enrollment of the first patient in the Precision GRX registry is a major milestone for the company and we look forward to the participation of leading centers across the country,” president & CEO Mark Toland said in a press release. “We strongly believe that the improvements to the CorPath platform with GRX will further validate the widespread benefits and adoption of robotic-assisted PCI.”
The Precision GRX Registry will enroll up to 1,000 patients at 25 sites to research patient outcomes, economic benefits, procedural parameters and further robotic capabilities in PCI. Related sub-studies will look into the effects of robotics on left transracial access and wiring times.
“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,” added principal investigator Dr. Ehtisham Mahmud of UC San Diego Health and the Sulpizio Cardiovascular Center. “I look forward to spearheading the effort in evaluating this new technology and its value in current practice.”
Dr. Srini Potluri performed the procedure on the study’s first patient in Texas at the Heart Hospital Baylor Plano, which has two CorPath GRX Systems installed in its labs.
“I am excited to participate in the Precision GRX Registry to expand the depth of clinical research supporting robotic-assisted PCI,” he said. “Our participation emphasizes our continuous commitment to advancing patient care in interventional medicine.”
In May, Corindus released findings from its last post-market Precision registry study on the CorPath 200 system at the 2017 Society for Cardiovascular Angiography and Interventions Scientific Sessions.
After using the device in 754 patients, transracial access used in 452 cases and transfemoral cases used in 298 cases, the results revealed an 88.6% technical success rate and an 98.9% clinical success rate in transradial access cases and an 82.4% technical success rate and an 94.9% clinical success rate in transfemoral access cases.