Corindus today announced positive results from a study of its CorPath used in robotic-assisted neurovascular aneurysm embolization.
The Siemens Healthineers company, which develops precision vascular robotics, presented results from a first-of-its-kind study demonstrating the safety and effectiveness of robotic-assisted neurovascular aneurysm embolization using the CorPath GRX neurovascular system.
Newton, Massachusetts-based Corindus said the study is the world’s first trial on robotic-assisted neurovascular aneurysm embolization.
Dr. Michel Piotin, principal investigator and head of the interventional neuroradiology department at the Rothschild Foundation Hospital in Paris, presented results at the European Society of Minimally Invasive Neurological Therapy (ESMINT) Congress in Nice, France. It was a prospective, single-arm, international, multi-center, non-inferiority study.
CorPath GRX demonstrated 94% technical success. Corindus said it achieved its primary effectiveness goal. The goal is successful completion of the robotic-assisted endovascular procedure absent of any unplanned conversion to a manual procedure. It also demonstrated 95.7% clinical success.
The company said 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.
Additionally, 64.5% of subjects achieved Class I status. This means they experienced the complete obliteration of the aneurysm, on the Raymond-Roy Occlusion Classification (RROC), the standard for evaluating aneurysm occlusion. Corindus said 78.2% of subjects showed no clinical symptoms post-procedure.
“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.”
Study makeup
The study evaluated 117 patients across 10 clinical sites in six countries. It included a wide range of aneurysms for a diverse collection of cases. The aneurysms featured different locations, sizes and morphology characteristics. Healthcare facilities that treated participants will follow them for 180 days to monitor 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, CMO of 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.”
The CorPath GRX System FDA-cleared and CE-marked for percutaneous coronary and vascular procedures. It earned CE Mark for neurovascular procedures. Healthcare facilities outside of the U.S. currently utilize the platform for neurovascular interventions. The company is currently pursuing additional regulatory clearances for the neurovascular indication.