September 18, 2025

Sentante Stroke System Receives FDA Breakthrough Device Designation

September 18, 2025—Sentante, a Lithuania-based medical technology company, announced that the FDA has granted Breakthrough Device designation for the Sentante stroke system. The device is intended for the remote delivery and manipulation of endovascular devices for the removal of thrombus from intracranial vessels in patients with acute ischemic stroke who are in remote hospitals without access to local manual thrombectomy or timely transfer to a thrombectomy-capable center.

Sentante advised that the system is designed to be used by trained neurointerventional physicians to remotely perform mechanical neurothrombectomy procedures using compatible endovascular devices.

According to the company, the Sentante stroke system is intended to eliminate the need for patient transfers to specialized centers, thereby expanding access to care, reducing disparities, and improving outcomes for patients experiencing acute ischemic stroke, regardless of their geographic location.

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September 18, 2025

Sentante Stroke System Receives FDA Breakthrough Device Designation

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