Mentice recently announced that Ankyras, the company’s clinical decision support application, has received 510(k) clearance from the US Food and Drug Administration (FDA). The approval of this product by the FDA demonstrates the safety and effectiveness of Ankyras, and confirms Mentice’s commitment to providing innovative and high-quality healthcare solutions, as per a company press release.
The software is designed to assist interventional neuroradiologists in selecting the most suitable flow diverter prior to the interventional treatment of intracranial aneurysms. Ankyras offers an “intuitive and precise solution” for clinical treatment planning, leading to more accurate predictions than traditional methods, the release adds.
It is a platform that provides users with various functionalities to investigate device and treatment options in greater detail. Mentice states that the platform offers unique morphological assessment metrics that provide customers with a comprehensive and interactive analysis of all artery segments, ensuring they are better equipped to handle real-life challenges. The platform has technology supported by a “strong” intellectual property (IP) portfolio that enables users to evaluate final device length, local expansion and porosity, and precisely align the centreline 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 USA is the single largest market for flow diverters, and devices from all major manufacturers in the USA 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 preprocedural clinical planning, 3D-printed physical simulation, and virtual simulation, we can offer significant benefits to both hospitals and industry.”
Moving forward, Mentice plans to continue improving the Ankyras solution by incorporating advanced functionalities and more treatment modalities, as well as integrating it with other Mentice solutions—especially the recently acquired Biomodex line of biorealistic haptic simulators.
