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:
- The CorPath GRX Neurovascular System demonstrated 94 percent technical success. It 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 CorPath GRX Neurovascular System demonstrated 95.7 percent 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.
- 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.
- 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.”
The CorPath GRX System is the first FDA-cleared and CE Marked medical device for percutaneous coronary and vascular procedures. It earned CE Mark for neurovascular procedures, and 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.
To learn more about CorPath GRX, please visit www.corindus.com.
Corindus, A Siemens Healthineers Company, is a global technology leader in robotic-assisted vascular interventions. The Company’s CorPath® platform is a medical device to bring robotic precision to percutaneous coronary and vascular procedures. CorPath GRX is the second-generation robotic-assisted technology offering enhancements to the platform by adding important key upgrades that increase precision, improve workflow, and extend the capabilities and range of procedures that can be performed robotically. We are focused on developing innovative robotic solutions to revolutionize treatment of emergent conditions by providing specialized and timely medical care to patients around the world. For additional information, visit www.corindus.com, and follow @CorindusInc.