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Multicenter post-market registry designed to collect data on routine use of the CorPath GRX System.
September 27, 2017
By: Business Wire
Corindus Vascular Robotics Inc., a developer of precision vascular robotics, has announced the first patient enrollment in the PRECISION GRX Registry, a post-market study to continue market surveillance of the company’s second generation CorPath GRX System. The PRECISION GRX Registry will include up to 25 sites and enroll up to 1,000 patients receiving robotic-assisted percutaneous coronary intervention (PCI). The study will gather data to evaluate patient outcomes, potential economic benefits, procedural parameters and the expanding capabilities of robotics in PCI. Additional sub-studies will seek to evaluate the impact of robotics on left transradial access and robotic wiring times. Dr. Ehtisham Mahmud, division chief of UC San Diego Health, Cardiovascular Medicine and Medical Director, Sulpizio Cardiovascular Center, has been named as the global principal investigator for the PRECISION GRX Study. “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,” said Mahmud, M.D. “I look forward to spearheading the effort in evaluating this new technology and its value in current practice.” The procedure on the first patient in the trial was performed by Dr. Srini Potluri at The Heart Hospital Baylor Plano, one of two Baylor hospitals participating in the registry. The hospital currently has two CorPath GRX Systems installed in its catheterization labs. Potluri stated, “I am excited to participate in the PRECISION GRX Registry to expand the depth of clinical research supporting robotic-assisted PCI. Our participation emphasizes our continuous commitment to advancing patient care in interventional medicine.” “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,” said Mark Toland, president and CEO of Corindus. “We strongly believe that the improvements to the CorPath platform with GRX will further validate the widespread benefits and adoption of robotic-assisted PCI.” Corindus Vascular Robotics Inc. is a global technology leader in robotic-assisted vascular interventions. The company’s CorPath System is the first U.S. Food and Drug Administration-cleared medical device to bring robotic precision to percutaneous coronary interventions. During the procedure, the interventional cardiologist sits at a radiation-shielded workstation to advance guide catheters, stents, and guidewires with millimeter-by-millimeter precision. The workstation allows the physician greater control and the freedom from wearing heavy lead protective equipment that causes musculoskeletal injuries. With the CorPath System, Corindus Vascular Robotics brings robotic precision to interventional procedures to help optimize clinical outcomes and minimize the costs associated with complications of improper stent placement during manual procedures.
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