Sentante secures CE mark for robotic endovascular surgery platform ahead of European rollout

LITHUANIA—Sentante has received CE mark approval for its endovascular robotic surgery platform, clearing the way for commercial deployment across Europe as demand for remote and minimally invasive surgical technologies grows.

The certification marks a major step for the Lithuania-based medical technology company, allowing it to market and sell its robotic platform within European healthcare systems after several years of development, testing, and regulatory review.

Remote-Controlled Procedures Designed for Precision

Sentante’s platform enables clinicians to perform endovascular procedures remotely through a teleoperated workstation equipped with haptic feedback controls and multiple operating room displays.

The technology is designed to support interventions such as balloon angioplasty and stent placement while reducing physicians’ radiation exposure and improving procedural precision.

Following the CE mark approval, the company plans to begin its initial European rollout by partnering with hospitals and healthcare providers seeking to integrate robotic-assisted vascular procedures into routine clinical care.

Sentante also said it will continue investing in physician training programs while expanding its commercial operations and advancing additional products in its pipeline.

Edvardas Satkauskas, co-founder and chief executive officer of Sentante, described the approval as a defining milestone for the company.

He said the certification validates both the technology itself and the work undertaken to meet European regulatory requirements, adding that the company is now ready to move into full commercialisation.

The company’s co-founder, Dr. Tomas Baltrunas, also stated that Sentante has spent recent years building the infrastructure needed to transition from a research-focused organisation into a commercial-stage medical robotics business capable of scaling across healthcare markets.

Clinical study supported regulatory approval

The CE mark was supported by data from the ESSENTIAL clinical study (NCT06537947), which evaluated the platform’s safety and effectiveness during remote peripheral vascular interventions performed at Paula Stradiņš Clinical University Hospital.

The study included first-in-human procedures completed in July 2024. During those interventions, clinicians used the robotic platform to conduct procedures including balloon angioplasty and stent delivery.

Professor Dainis Krievins, who led the trial and carried out the procedures, previously reported that the robotic system demonstrated strong precision and stable procedural performance during the early cases.

Expanding presence in robotic surgery and stroke care

The latest regulatory milestone follows another important achievement for Sentante in September 2025, when the company received breakthrough device designation from the US Food and Drug Administration for its remote stroke intervention system.

That system is intended for the remote manipulation and delivery of endovascular devices used to remove blood clots from intracranial vessels in patients experiencing acute ischemic stroke.

The technology was also accepted into the FDA’s Total Product Life Cycle Advisory Program, which supports the development and review of innovative medical devices.

Sentante recently introduced a digital indeflator system designed to replace traditional manual indeflators used during angioplasty and stent procedures, further broadening its vascular intervention portfolio.

The company enters a rapidly expanding robotic surgery market that analysts expect to reach approximately US$17.3 billion by 2035.

Other firms developing robotic and remote surgical technologies include Microbot Medical and Sovato.