Sentante Enters FDA TAP Program for Remote Stroke System

February 18, 2026—Sentante announced that its Sentante stroke system has been accepted into the FDA Total Product Life Cycle Advisory Program (TAP), building on the Breakthrough Device designation granted in September 2025 and advancing the company’s regulatory pathway toward first-in-human remote stroke trials.

According to the company’s press release, thousands of devices are cleared by the FDA each year, whereas fewer than 200 annually receive Breakthrough Device designation, and an even smaller subset is selected for the TAP pilot. Sentante stated that it is the only endovascular robotic system with Breakthrough Device designation for stroke thrombectomy. TAP provides early and ongoing engagement with the FDA and partner agencies across clinical development, regulatory strategy, market access, and postmarket evidence generation. For interventionalists, TAP inclusion signals closer alignment with the agency as Sentante prepares to seek an investigational device exemption (IDE) for remote mechanical thrombectomy studies in acute ischemic stroke.

“Acceptance into the FDA’s TAP Program provides strong validation of both the urgency and the credibility of what we are building,” said Edvardas Satkauskas, CEO of Sentante. “TAP is about strategic support—we will be working hand-in-hand with the FDA to navigate external hurdles like insurance (reimbursement) and faster doctor adoption, helping us to derisk and accelerate the pathway to commercial success.”

Mechanical thrombectomy is the standard of care for large-vessel occlusion stroke, but access remains limited. The company noted that > 60% of the United States population does not have timely access to a thrombectomy-capable center. Sentante’s device-agnostic, haptic endovascular robotic platform is designed to allow neurointerventionalists to perform thrombectomy remotely using off-the-shelf catheters and guidewires, with tactile feedback transmitted over a secure network.

Over the past year, the company reported completing a transatlantic remote stroke thrombectomy on perfused human cadaver models and a multiday Good Laboratory Practice (GLP) live-subject study comprising 24 remote thrombectomy procedures conducted from three continents. “Our recent live-subject GLP studies demonstrated that the system can safely and precisely operate in complex, living biological environments,” said Tomas Baltrunas, MD, Co-Founder and Chief Medical Officer of Sentante. “TAP allows us to build directly on that evidence with early regulatory input, helping ensure that our clinical strategy is robust, efficient, and focused on patient safety.”

Under TAP, initial discussions will focus on clinical trial design, endpoints, and risk mitigation strategies to support an IDE application for first-in-human remote stroke studies. In parallel, the company stated that it is pursuing regulatory clearance for a peripheral vascular indication, positioning the platform as a multivascular robotic system.

Sentante, founded in 2017, develops a haptic, device-agnostic endovascular robotic platform intended for remote performance of neurovascular, peripheral vascular, and cardiovascular procedures, according to the company.