FDA sees promise in remote robotic-assisted stroke device

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FDA sees promise in remote robotic-assisted stroke device

Vitor Mendes Pereira, MD, performs the first telerobotic procedure of its kind on a stroke patient 120 miles away. Fred Moll, chairman of XCath Robotics, looks on. Image courtesy of XCath Robotics.

XCath Robotics has received the FDA's breakthrough device designation for its Iris surgical robotic system that performs remote robotic-assisted mechanical thrombectomy in acute ischemic stroke patients.

This represents a significant step forward for the Houston-based medtech company. The FDA's breakthrough devices drogram helps support the development of medical devices that have the potential to provide more effective treatment for patients with life-threatening or irreversibly debilitating conditions. This provides XCath Robotics with more opportunities to interact with FDA experts and receive support as the company works toward U.S. regulatory approval for the Iris system.

Back in March, the Iris system was used to complete the world’s first telerobotic stroke thrombectomy. Neurosurgeon Vitor Mendes Pereira, MD, chair of advanced neurovascular interventions at the University of Toronto, used the system to perform the historic procedure in Santiago, Panama, while the patient was 120 miles away in Panama City.

XCath Robotics said the Iris technology could open the door to breaking down the geographic barriers to specialist stroke care. Mechanical thrombectomy is widely regarded as the gold standard treatment for patients suffering a large vessel occlusion (LVO) stroke, which is the deadliest and most disabling type of ischemic stroke. However, access to the procedure remains limited outside of major cities, both in the U.S. and internationally.

The global median rate of access to mechanical thrombectomy is only about 2.79%. LVO strokes, similar to heart attacks, have a limited window for treatment before irreversible damage is caused as brain tissues dies. About 77% of patients either die or are left with severe disability.

The U.S. government has recently shown interest in expanding access to robotic stroke thrombectomy. This includes funding through the Advanced Research Projects Agency for Health (ARPA-H) to accelerate the development of an autonomous, remote endovascular robotic system that perform mechanical thrombectomy on stroke patients. Siemens Healthineers was awarded $31.1 million to accelerate the development of an autonomous, remote endovascular robotic system that can perform thrombectomy on stroke patients. Philips Healthcare was also awarded $33.7 million to develop an autonomous robotic system with partners Johns Hopkins University, Boston University and Weill Cornell Medicine.