Sam Brusco, Associate Editor01.04.24
Mentice has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ankyras clinical decision support application.
The software was designed to help interventional neuroradiologists select the most suitable flow diverter prior to interventional treatment of intracranial aneurysms. The company said Ankyras provides an intuitive, precise tool for clinical treatment planning and can bring about more accurate prediction than traditional methods.
Ankyras offers morphological assessment metrics that provides a comprehensive, interactive analysis of all artery segments, making sure they’re equipped to handle real-life challenges. Users can use Ankyras to evaluate final device length, local expansion and porosity, and align the centerline to create accurate simulations for specific devices.
"Obtaining 510(k) clearance for Ankyras has been the number one priority since the beginning of last year, and we are pleased that we have achieved this major regulatory milestone," said Héctor Fernández, director of Ankyras Development. “The United States is the single largest market for flow diverters, and devices from all major manufacturers in the U.S. will now be available through Ankyras. This demonstrates our unwavering commitment to our expressed strategy of expanding into patient-specific decision support applications, which we believe will offer significant synergies with our existing training offering. By relying on a single provider for both pre-procedural clinical planning, 3D-printed physical simulation and virtual simulation, we can offer significant benefits to both hospitals and industry."
Mentice said it plans to keep improving Ankyras with advanced functionalities and more treatment modalities, as well as integrating it with the recently acquired Biomodex line of biorealistic haptic simulators.
The software was designed to help interventional neuroradiologists select the most suitable flow diverter prior to interventional treatment of intracranial aneurysms. The company said Ankyras provides an intuitive, precise tool for clinical treatment planning and can bring about more accurate prediction than traditional methods.
Ankyras offers morphological assessment metrics that provides a comprehensive, interactive analysis of all artery segments, making sure they’re equipped to handle real-life challenges. Users can use Ankyras to evaluate final device length, local expansion and porosity, and align the centerline to create accurate simulations for specific devices.
"Obtaining 510(k) clearance for Ankyras has been the number one priority since the beginning of last year, and we are pleased that we have achieved this major regulatory milestone," said Héctor Fernández, director of Ankyras Development. “The United States is the single largest market for flow diverters, and devices from all major manufacturers in the U.S. will now be available through Ankyras. This demonstrates our unwavering commitment to our expressed strategy of expanding into patient-specific decision support applications, which we believe will offer significant synergies with our existing training offering. By relying on a single provider for both pre-procedural clinical planning, 3D-printed physical simulation and virtual simulation, we can offer significant benefits to both hospitals and industry."
Mentice said it plans to keep improving Ankyras with advanced functionalities and more treatment modalities, as well as integrating it with the recently acquired Biomodex line of biorealistic haptic simulators.