Corindus, a precision vascular robotics company of Siemens Healthineers, has unveiled the positive safety and effectiveness results for its CorPath GRX Neurovascular System.
The company announced the results from a single-arm, multi-centre, non-inferiority study of robotic-assisted neurovascular aneurysm embolisation using its CorPath GRX system.
In the study, CorPath GRX Neurovascular System showed 94% technical success, and 95.7% clinical success, and has achieved both primary goals of effectiveness and safety.
The CorPath GRX System is the first medical device to receive the US FDA and CE mark approvals for percutaneous coronary and vascular procedures, said Corindus.
Corindus Neuroendovascular chief medical officer Raymond Turner said: “The work of our clinical partners on this study marks an early step toward truly transformative change in neurovascular intervention.
“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.”
The study recruited 117 patients from 10 clinical sites in six different countries and is the world’s first study on robotic-assisted neurovascular aneurysm embolisation.
The participants will be followed up for 180 days to monitor extended, long-term outcomes.
In the study, 64.5% of participants achieved Class I status, which indicates a complete obliteration of the aneurysm, on the Raymond-Roy Occlusion Classification (RROC).
The RROC is considered the standard for evaluating aneurysm occlusion.
Also, 78.2% of the study participants showed no clinical symptoms after the procedure, achieving as measured by the Modified Rankin Scale (mRS) for Neurologic Disability.
Principal investigator Michel Piotin said: “Neurovascular intervention demands extreme precision to achieve optimal clinical outcomes.
“The results of the study show the CorPath GRX System helps physicians move efficiently within tortuous and unstable vessels.
“I am honoured to have participated in a groundbreaking study that may lead to an entirely new treatment paradigm in neurovascular care.”
