Mentice announced that the clinical decision support application ANKYRAS has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The approval of product by the FDA demonstrates the safety and effectiveness of Ankyras and confirms commitment to providing innovative and high-quality healthcare solutions. The software is designed to assist interventional neuroradiologists in selecting the most suitable flow diverter before interventional treatment of intracranial aneurysms. Ankyras offers an intuitive and precise solution for clinical treatment planning, leading to more accurate prediction than traditional methods.

In the United States, it is estimated that 6.7 million individuals have an unruptured brain aneurysm, meaning that 1 out of every 50 people may be affected. Shockingly, every year, approximately 30,000 people experience a rupture in their brain aneurysm. Unfortunately, this rupture is fatal in nearly 50% of cases.

Of those who survive, about 66% suffer some permanent neurological deficit. Ankyras is a platform that provides users with various functionalities to investigate device and treatment options in greater detail. It 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 IP portfolio that enables users to evaluate final device length, local expansion and porosity, and precisely align the centerline to create accurate simulations for specific devices. 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. To stay up-to-date with the latest Ankyras advancements and its role in device development and treatment strategies for Intracranial Aneurysm Foundation.