Sentante recently shared that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company’s robotic stroke system.
A press release details that the Sentante stroke system allows for the remote delivery and manipulation of endovascular devices to remove thrombus from intracranial vessels. It is designed for use in patients with acute ischaemic stroke who are in remote hospitals without access to local manual thrombectomy or timely transfer to a thrombectomy-capable centre. Sentante notes that the system is intended to be used by trained neurointerventional physicians to remotely perform mechanical neurothrombectomy procedures using compatible endovascular devices.
“This innovation will expand access to care, reduce disparities, and improve outcomes for patients suffering from acute ischaemic stroke, regardless of their geographic location,” Sentate notes.
“Receiving Breakthrough Device designation for the Sentante stroke system is a major milestone in our mission to transform stroke care,” said Edvardas Satkauskas, chief executive officer of Sentante. “This recognition from the FDA highlights the potential of our technology to address a critical healthcare challenge and bring hope to millions of stroke patients.”
Tomas Baltrūnas, chief medical officer of Sentante, added: “This technology could redefine access to stroke care, ensuring that geography is no longer a determinant of outcomes for patients suffering from acute ischaemic stroke. We are committed to making timely, life-saving interventions available to all who need them.”
