Sentante Wins CE Mark for Endovascular Surgery Robot

Sentante has secured CE-mark approval for its haptic endovascular robotic platform, allowing the stroke-focused system to be marketed across Europe.

Sentante Wins CE Mark for Endovascular Surgery Robot

Sentante endovascular surgical robot system

Lithuanian medical robotics company Sentante announced on May 21, 2026 that it has secured CE-mark approval for its flagship endovascular robotic platform, clearing the way to market and sell the system across European markets. The company described the certification as a "major transition" from research and development to full commercial readiness.

How the platform works

Sentante's haptic robotic system is built to perform endovascular procedures using standard cath-lab equipment such as guidewires and catheters. A high-resolution sensory console captures a specialist's hand movements, and a robot at the patient's bedside replicates those manipulations in real time. Unlike joystick-controlled surgical robots, the platform is designed to deliver authentic force feedback to the operator's fingertips, and it can be operated either nearby or remotely, raising the prospect of treating patients far from specialist centers.

Built for stroke and vascular care

The platform targets endovascular interventions, with a particular focus on stroke treatment, where rapid access to skilled operators can be decisive. The CE mark was supported by clinical validation from the company's ESSENTIAL study, which carried out first-in-human procedures in July 2024 at Paula Stradins Clinical University Hospital in Riga, Latvia, evaluating the system's safety and effectiveness in remote peripheral interventions such as balloon angioplasty and stent delivery.

From R&D to commercialization

"This is a defining moment for Sentante," said chief executive and co-founder Edvardas Satkauskas, calling the approval "a validation of our technology" and of the work required to meet the highest regulatory standards. Co-founder Tomas Baltrunas said the company had built the foundations "not only to launch successfully, but to scale." Sentante said it will now focus on initial market rollout, clinician training and expanding its commercial footprint, while advancing a product pipeline that recently added a precision-controlled digital indeflator to replace the manual device used in angioplasty and stent procedures.

A crowded surgical robotics field

Sentante enters a fast-moving market in which established and emerging players are racing to broaden robotic surgery beyond its traditional strongholds. The milestone follows a steady stream of regulatory wins for robotic platforms, including expanded U.S. clearance for the da Vinci 5 system, and growing clinical evidence that AI-assisted robotic surgery can improve precision and recovery. It also adds to momentum in medical-grade robotics built for clinical environments.

Reporting based on coverage from Vascular News, MassDevice and MedTech Dive.

Category: Surgical Robotics

Tags: Surgical Robotics Medical Robotics minimally invasive surgery european robotics robotic surgery

Related Articles