NEWTON, Mass.--(BUSINESS WIRE)--Corindus, A Siemens Healthineers Company and a leading developer of precision vascular robotics, announced today it presented the results of a first-of-its-kind study demonstrating the safety and effectiveness of robotic-assisted neurovascular aneurysm embolization using the CorPath GRX Neurovascular System. The data represents a milestone in the company’s commitment to extending precision robotics into neurovascular treatment.
The prospective, single-arm, international, multi-center, non-inferiority study is the world’s first trial on robotic-assisted neurovascular aneurysm embolization. Principal Investigator Michel Piotin, MD, PhD, Head of the Interventional Neuroradiology Department at the Rothschild Foundation Hospital in Paris, presented the results as part of the AI & New Innovations session at the European Society of Minimally Invasive Neurological Therapy (ESMINT) Congress in Nice, France. Key findings of the study showed:
64.5 percent of subjects achieved Class I status, meaning complete obliteration of the aneurysm, on the Raymond-Roy Occlusion Classification (RROC), the standard for evaluating aneurysm occlusion.
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78.2 percent of subjects showed no clinical symptoms post-procedure, achieving a 0 on the Modified Rankin Scale (mRS) for Neurologic Disability. The remaining 21.8 percent of subjects had an mRS of 1 or 2.
“Neurovascular intervention demands extreme precision to achieve optimal clinical outcomes,” said Dr. Piotin. “The results of the study show the CorPath GRX System helps physicians move efficiently within tortuous and unstable vessels. I am honored to have participated in a groundbreaking study that may lead to an entirely new treatment paradigm in neurovascular care.”
The study included 117 patients from 10 clinical sites in six different countries. It also included a wide range of aneurysms, representing a diverse collection of cases with different locations, sizes and morphology characteristics. The healthcare facilities that treated the trial participants will follow them for 180 days to monitor extended, long-term outcomes.
“The work of our clinical partners on this study marks an early step toward truly transformative change in neurovascular intervention,” said Dr. Raymond Turner, Chief Medical Officer, Neuroendovascular at Corindus. “By incorporating robotic platforms in this space, we are paving the way for remote interventional procedures in the future that will connect patients to specialized interventionalists for treatment, regardless of location. Validating clinical evidence, such as this study, will serve as the foundation for that transformation.”