Robotic-Assisted Neurovascular System Provides Safe and Effective Aneurysm Embolization
A prospective, noninferiority study demonstrated safety and effectiveness of a robotic-assisted neurovascular aneurysm embolization system (CorPath GRX Neurovascular System; Corindus, Waltham, MA). The system is the first to have been cleared by the Food and Drug Administration (FDA) for percutaneous coronary and vascular procedures. Clearance from the FDA is being pursued for a neurovascular indication, which has already been approved outside the US.
In 117 individuals treated, there was a 94% technical success rate, defined as successful completion of the robotic-assisted endovascular procedure without unplanned conversion to a manual procedure. In 95.7% of cases treated, there were no intraprocedural or periprocedural adverse events, including target aneurysmal rupture, vessel perforation or dissection, and thromboembolic events with neurologic decline within 24 hours after the procedure or hospital discharge.
“Neurovascular intervention demands extreme precision to achieve optimal clinical outcomes,” said Michel Piotin, MD, PhD, head of the Interventional Neuroradiology Department, Rothschild Foundation Hospital, Paris. “The results of the study show the CorPath GRX system helps physicians move efficiently within tortuous and unstable vessels.”
A wide range of aneurysm locations, sizes, and morphology were treated in this study at 10 clinical sites in 6 different countries. It also included a wide range of aneurysms, representing a diverse collection of cases with different locations, sizes, and morphology characteristics.
Complete obliteration of the aneurysm, or class 1 status on the Raymond-Roy Occlusion Classification (RROC), was achieved in 64.5% of cases and 78.2% had no clinical symptoms after the procedure (0 on the Modified Rankin Scale [mRS]). No participants had a mRS greater than 2.
These data were presented at the European Society of Minimally Invasive Neurological Therapy (ESMINT) Congress in Nice, France.