Medical robotics company Sentante has conducted its first study involving live subjects, with surgeons using its unique haptic endovascular platform on animal models from three different remote locations. The study’s aim was to test the effectiveness of Sentante’s platform in delivering remote stroke thrombectomy procedures where the specialist and patient are separated by thousands of miles—and, according to a press release disseminated earlier today, it marks a “critical step” in the company’s rapid progress towards human trials as well as making gold-standard stroke treatments more accessible.
The intensive three-day study involved 24 stroke thrombectomy procedures performed remotely from three sites—in Orlando, USA; Dundee, UK; and Vilnius, Lithuania—on live animal subjects located at the Veranex facility in Paris, France. The test team performed an array of fully remote procedures, including diagnostics, the navigation of endovascular devices, and the removal of thrombus material from live arteries.
“I was genuinely surprised by how effortlessly the robot handled all the steps in the procedure,” said Ricardo Hanel (Baptist Medical Center, Jacksonville, USA). “It took less than a minute to shift robot control from the centre in Europe to here in Florida, and the devices did not move at all. I was able to continue the procedure from exactly the same position where the devices had been left a moment earlier by the European doctors. Navigation was smooth, stable and incredibly accurate, giving me total control at every step. The system is ready for use in human patients.”
The study follows a “world-first” remote thrombectomy procedure performed using Sentante’s platform on perfused human cadaver subjects at a hospital in Dundee by two clinicians located remotely, including one in Jacksonville. This remote interface—with haptic, near-real-time feedback simulating the tactility of a bedside location—made the trial’s success a “significant leap forward” in the ability for specialists to perform interventions on patients suffering life-threatening or life-limiting stroke events from afar, Sentante claims. Both specialists—Hanel and Iris Grunwald (University of Dundee, Dundee, UK)—also took part in the latest live trials.
“The encouraging results from our study in Dundee allowed us to accelerate our timeline,” commented Tomas Baltrunas, co-founder and chief medical officer of Sentante. “What we’re testing here goes beyond simply removing a clot remotely; we’re validating the technology in living systems—managing fluids, avoiding injury and vessel damage, dealing with the many things that come into play when you’re working with a real living organism, and maintaining the speed and urgency to make real-time decisions. These are preclinical data that directly lay our route to treating patients.”
Sentante details that the live trial invited observations from the attending specialists with a view to understanding the performance and physical experience of the technology, and its potential within human endovascular applications in particular.
“Sentante’s robot allowed me to conduct five transatlantic stroke thrombectomies in an animal model in just a couple of hours,” said Vitor Pereira (University of Toronto, Toronto, Canada). “It reflects how rapidly robotic solutions for stroke care are advancing and the exciting potential for future applications. I see this technology as fully ready for use in humans, and a clinical trial should be started as soon as possible.”
“In stroke treatment, achieving the optimal balance between speed and precision is always a challenge,” added Vincent Costalat (University Hospital of Montpellier, Montpellier, France). “Sentante strikes that balance perfectly for mechanical stroke thrombectomy.”
Sentante states that its haptic platform differs from joystick-controlled surgical devices by delivering authentic force feedback directly to the surgeon’s fingertips, “replicating the tactile experience of manual surgery but from a distance of thousands of miles”. The system works with standard catheterisation laboratory equipment and devices, and has benefits for specialists—including reduced radiation exposure and physical strain—as well as for patients, including access to specialist care in remote locations and enhanced medical support.
Data gathered during every stage of the procedures have an “unprecedented richness” that will further refine the process and assist training, the company also avers, with Grunwald commenting that “Sentante will change the way we train for stroke thrombectomies”.
“The haptic feedback of the robotic system is exceptional,” Grunwald also said. “You feel exactly what the device is doing, even though you’re operating it remotely. We are used to specific devices and, with Sentante, you can use the same devices as in real life; Sentante is device-agnostic [and] open-platform-compatible with the best-in-class, off-the-shelf endovascular devices. The subtle, tactile cues give you confidence in every movement. It’s almost like having your hands directly on the catheter, but with even greater stability.”
While utilisation of the company’s platform for peripheral vascular interventions is already progressing towards regulatory clearance, its usage in stroke thrombectomy still needs to navigate the established clinical pathway of preclinical validation followed by first-in-human studies and, ultimately, full clinical trials.
“Remote stroke treatment requires precision, stability, safety and teleoperation all at once,” said Edvardas Satkauskas, chief executive officer (CEO) of Sentante. “Our platform was built from day one to deliver exactly that. We’re not just developing technology; we’re developing a complex and needed solution to a growing gap in care that costs lives and independence every day.”
