Sentante has announced that its robotic system has been accepted into the US Food and Drug Administration’s (FDA) total product life cycle advisory programme (TAP), which provides selected medical device developers with early, frequent and strategic engagement with the regulator and its partner agencies across the full product life cycle—from clinical development and regulatory strategy through to market entry and post-market evidence generation.
Through the programme, Sentante says it will work closely with the US FDA to align on clinical trial design, endpoints, risk mitigation strategies and evidence requirements ahead of first-in-human studies. Initial engagement under TAP will focus on defining the pathway toward an investigational device exemption (IDE) for remote stroke thrombectomy clinical studies, as stated in a press release. In parallel, the company is continuing to advance regulatory clearance for its peripheral vascular indication.
This TAP acceptance follows the Breakthrough Device designation granted to the Sentante system by the US FDA in September 2025.
“Acceptance into the FDA’s TAP programme provides strong validation of both the urgency and the credibility of what we are building,” said Edvardas Satkauskas, chief executive officer (CEO) of Sentante. “Breakthrough Device designation recognised the game-changing nature of this technology and provided a ‘VIP pass’ for regulatory-related communication with the FDA. 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.”
While mechanical thrombectomy has become the gold-standard treatment for large vessel occlusion (LVO) stroke, access remains “severely limited”, as more than 60% of people in the USA—and a far greater proportion of the global population—do not have timely access to a thrombectomy-capable centre, Sentante claims.
“Geography should never determine whether someone survives a stroke or lives with permanent disability,” Satkauskas added.
Sentante’s multi-domain, device-agnostic endovascular platform is designed to overcome this gap by enabling expert neurointerventionists to perform thrombectomy procedures remotely, with full tactile feedback, using standard off-the-shelf catheters and guidewires. The company’s system allows a physician to come to the patient over a secure network, eliminating delays associated with long-distance transfers and limited specialist availability.
Sentante says that—over the past year—its robotic platform has advanced through multiple other major milestones, including a “world-first” transatlantic remote stroke thrombectomy performed on perfused human cadaver models, and a multi-day good laboratory practice (GLP) live-subject study involving 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 Baltrūnas, 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.”
