Dive Brief:
- Sentante has received CE mark approval for its robotic platform for endovascular surgery, clearing the medtech company to sell the system across Europe.
- The certification comes three months after the Food and Drug Administration accepted the Lithuania-based company’s namesake stroke care system into its total product life cycle advisory program, also known as TAP, that is designed to bring innovative medical technologies to patients more quickly.
- Sentante co-founder Tomas Baltrunas, in a Wednesday statement, said the company is now transitioning to a commercial stage organization and has prepared the foundation to scale up its platform’s launch.
Dive Insight:
Sentante’s platform is designed to enable specialists to perform complex vascular procedures remotely with tactile feedback, using standard catheters and guidewires. The surgeon operates over a secure network, with the goal of eliminating delays associated with long-distance patient transfers and limited specialist availability, according to the company.
Sentante entered the TAP program after receiving the FDA’s breakthrough device designation for the system in September, recognizing the technology’s potential to address a critical unmet need in stroke care. The intent is for the neurointerventionalist to be able to remove blood clots from intracranial vessels in patients with acute ischemic stroke who are in remote hospitals without access to local manual thrombectomy or timely transfer to a capable center.
The company said in February that it was preparing for first-in-human remote stroke trials, with initial work under TAP aimed at defining the pathway for an investigational device exemption for remote stroke thrombectomy. Sentante is also pursuing regulatory clearance for a peripheral vascular indication.
With its CE mark certification, the company said it is focused on an initial market rollout and clinician training, while continuing to develop its product pipeline.
