Over a lifetime, 1 in 20 Europeans suffers from abdominal aortic aneurysm (AAA), a dangerous, progressive dilation of the aorta, the largest blood vessel of the human body. If rupture occurs, 80% of patients die due to rapid internal bleeding. AAAs thus claim more lives annually in Europe than traffic accidents.
AAAs with diameters of 3-5 cm are termed small (early stage), while those with diameters greater than 5-5.5 cm are classified as large (late stage). Currently, 9 out of 10 patients are diagnosed with early AAAs, yet physicians cannot offer any therapy, as existing prosthetic treatments are reserved for late stage AAAs due to high complication rates and mortality. Consequently, patients remain without treatment and live with the psychologically trying threat of a "ticking time bomb" in their body.
The Angiolutions device “A3 Shield” is a first-of-its-kind device stopping the life-threatening progression of early-stage AAA. Angiolutions’ award-winning and patent-protected solution leverages a fundamentally new understanding of AAA growth discovered by the founders at Stanford University. They showed that aortic pulse waves, generated with every heartbeat, drive AAA progression. Based on this principle and together with key physicians, they developed a minimally-invasive, non-active aortic implant (class III). The nitinol-based device is positioned adjacent to the aneurysm sac via simple, catheter-based implantation. It is specifically designed to focally block aortic pulse waves from impacting the AAA . Hereby, they achieve a fast, low-risk, size-stabilizing treatment of small AAA.
The project is generally designed to 1) finish R&D activities prior to Angiolutions first-in-human study and 2) submit for regulatory clearance (CE mark) for the Angiolutions device within the scope of the “grant component” plus 3) initiate its commercialization thereafter with help of the “investment component”.
Angiolutions’ innovation will entirely change the present AAA therapy space as it unlocks the market for small AAA that cannot be addressed by current technologies. For the first time, patients will have access to a treatment that addresses their disease already at an early stage. At the same time, the treatment will prevent costly and risky interventions later on and therefore contribute to sustainable healthcare systems in Europe.