Corindus, a Siemens Healthineers company, announced today the recent presentation of results from a “first-of-its-kind” study demonstrating the safety and effectiveness of robotic-assisted neurovascular aneurysm embolisation using the CorPath GRX system. The data represent a milestone in the company’s commitment to extending precision robotics into neurovascular treatment, as per a press release.
The prospective, single-arm, international, multicentre, non-inferiority study is the world’s first trial concerning robotic-assisted neurovascular aneurysm embolisation, the release continues. Principal investigator Michel Piotin (Rothschild Foundation Hospital, Paris, France) presented the results at the 2022 European Society of Minimally Invasive Neurological Therapy (ESMINT) congress (7–9 September, Nice, France).
Key findings of the study showed:
- The CorPath GRX system demonstrated a 94% technical success rate and achieved the primary effectiveness goal—which was defined as successful completion of the robotic-assisted endovascular procedure absent of any unplanned conversion to a manual procedure
- The system also demonstrated a 95.7% rate of clinical success. It achieved the primary safety goal, defined as patients treated without intra- and periprocedural adverse events, including target aneurysmal rupture, vessel perforation or dissection, and thromboembolic event with neurological decline within 24 hours post-procedure or hospital discharge (whichever occurred first)
- Some 64.5% of subjects achieved Class I status, meaning complete obliteration of the aneurysm, on the Raymond-Roy occlusion classification (RROC)
- Some 78.2% of subjects showed no clinical symptoms post-procedure, achieving a modified Rankin Scale (mRS) score of zero, while the remaining 21.8% had an mRS of 1–2.
“Neurovascular intervention demands extreme precision to achieve optimal clinical outcomes,” said Piotin. “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.”
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, according to the release. The healthcare facilities that treated the trial participants are set to 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 Raymond Turner, chief medical officer, Neuroendovascular at Corindus/Siemens Healthineers. “By incorporating robotic platforms in this space, we are paving the way for remote interventional procedures in the future that will connect patients to specialised interventionalists for treatment, regardless of location. Validating clinical evidence, such as this study, will serve as the foundation for that transformation.”
The CorPath GRX system has earned CE-mark approval for neurovascular procedures, and healthcare facilities outside of the USA currently utilise the platform for neurovascular interventions. The company is also pursuing additional regulatory clearances of the system for neurovascular indications.