Corindus CorPath GRX Neurovascular System Demonstrates Safety and Effectiveness in Robotic-Assisted Aneurysm Embolization

September 12, 2022—Corindus, a Siemens Healthineers Company, announced the presentation of results from a first-of-its-kind study demonstrating the safety and effectiveness of robotic-assisted neurovascular aneurysm embolization using the company’s CorPath GRX neurovascular system.

According to the company, the prospective, single-arm, international, multicenter, noninferiority study is the first trial on robotic-assisted neurovascular aneurysm embolization.

The study was composed of 117 patients from 10 clinical sites in six countries. It included a wide range of aneurysms, representing a diverse collection of cases with different locations, sizes, and morphology characteristics. The health care facilities that treated the trial patients will follow them for 180 days to monitor long-term outcomes.

The study’s Principal Investigator is Michel Piotin, MD, who is Head of the Interventional Neuroradiology Department at the Rothschild Foundation Hospital in Paris, France.

Dr. Piotin presented the results during the AI & New Innovations session at the European Society of Minimally Invasive Neurological Therapy Congress 2022 held on September 7-9 in Nice, France.

“Neurovascular intervention demands extreme precision to achieve optimal clinical outcomes,” commented Dr. Piotin in the company’s press release. “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.”

In the press release, Corindus summarized the study’s findings as follows:

• 94% technical success was achieved.
• The primary effectiveness goal was met, which was defined as successful completion of the robotic-assisted endovascular procedure absent of any unplanned conversion to a manual procedure.
• 95.7% clinical success was achieved.
• The primary safety goal was met, which was defined as patients treated without intra- and periprocedural adverse events, including target aneurysmal rupture, vessel perforation or dissection, and thromboembolic event with neurologic decline within 24 hours postprocedure or posthospital discharge, whichever occurred first.
• 64.5% of patients achieved class I status (ie, complete obliteration of the aneurysm) on the Raymond-Roy Occlusion Classification.
• 78.2% of patients showed no clinical symptoms postprocedure, achieving a 0 on the Modified Rankin Scale (mRS) for neurologic disability. The remaining 21.8% of patients had an mRS of 1 or 2.

The CorPath GRX system has received FDA clearance and CE Mark approval for percutaneous coronary and vascular procedures.

For neurovascular procedures, the CorPath GRX system earned CE Mark approval. The platform is used for neurovascular interventions by health care facilities outside the United States. The company is currently pursuing additional regulatory clearances for the neurovascular indication, noted Corindus in the press release.