Sentante has gained a CE mark for its endovascular robotic surgery platform, priming the device for commercialisation in Europe.
The Lithuania-headquartered company’s system is teleoperated, allowing endovascular procedures to be performed from a remote workstation comprised of a haptic feedback wire and a series of screens displaying the operating room (OR).
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With CE mark in hand, Sentante will focus on the initial market rollout for its system, with plans to establish partnerships with hospitals and healthcare providers across Europe to integrate the technology into routine clinical practice.
Sentante also intends to continue its focus on clinician training and to explore further initiatives to expand its commercial footprint and continue advancing its product pipeline, the company stated, although it did not specify a timeframe for these aims.
Sentante’s CEO, Edvardas Satkauskas, commented: “Achieving CE mark is not only a validation of our technology, but also of the rigorous work undertaken by our team to meet the highest regulatory standards. We are now positioned to move decisively into commercialisation and begin delivering real impact for clinicians and patients.”
Sentante’s CE mark was supported by clinical validation data from the ESSENTIAL study (NCT06537947). Undertaking the first-in-human procedures in July 2024, the study evaluated the system’s safety and effectiveness in performing remote peripheral interventions such as balloon angioplasty and stent delivery at Paula Stradiņš Clinical University Hospital in Riga, Latvia.
Following completion of the first-in-human cases at the time, Dainis Krievins, professor in vascular and endovascular surgery at the university, who served as principal investigator of the trial and conducted the procedures, reported positive precision and performance of the robot.
Sentante’s CE mark follows its receival of breakthrough device designation from the US Food and Drug Administration (FDA) for its remote stroke system in September 2025. Indicated for the remote delivery and manipulation of endovascular devices for the removal of thrombus from intracranial vessels in patients with acute ischemic
stroke, this system has also been accepted onto the FDA’s Total Product Life Cycle (TAP) Advisory Program.
GlobalData analysis forecasts that the global robotic surgery market will reach a valuation of around $17.3bn in 2035. Other companies involved in the remote robotic surgery segment include Sovato and Microbot Medical.
