Cardiovascular disease remains the leading cause of death in Europe, responsible for 3.9 million deaths each year, roughly one every eight seconds, and costing over €210 billion annually in direct healthcare expenses. A significant share of this burden comes from strokes and heart failure associated with atrial fibrillation, a condition affecting millions of Europeans. Many high-risk patients cannot safely receive existing treatments because current heart implants are limited in adaptability, safety, or effectiveness.
The ALLIANCE Project, led by AuriGen Medical and funded by the European Innovation Council (EIC), set out to address this challenge by developing and validating a new generation of cardiac implants that combine stroke prevention with real-time heart monitoring. The project aimed to demonstrate that a modular implant system could be both safe and effective in humans, marking a major step toward personalized and minimally invasive treatment for complex cardiac patients.
The core technologies developed were:
Zenith – a next-generation device designed to seal the left atrial appendage (LAA), a small pocket in the heart where blood clots commonly form in patients with atrial fibrillation. By closing this area securely, Zenith helps prevent stroke without the need for long-term anticoagulant medication.
Halo – a miniature pressure sensor designed to monitor heart function continuously, enabling early detection of heart failure and providing real-time feedback to clinicians.
Together, these technologies form the basis of AuriGen’s modular implant platform, designed to integrate multiple therapies into a single, minimally invasive procedure.
During the project, Zenith progressed from laboratory prototype to a clinically validated system. The First-in-Human (FIH) clinical study enrolled ten patients (nine successfully implanted) and demonstrated excellent results: 100% of safety and performance endpoints were achieved, with no major complications or device-related adverse events. Imaging confirmed full healing of the implant within 45 days, a key milestone showing that the device integrates quickly and safely into the heart tissue. These outcomes position Zenith as a major advancement in stroke prevention technology and provide a strong evidence base for regulatory approval and wider clinical adoption.
Halo achieved major pre-clinical milestones during the project, including improvements in miniaturization, signal stability, and wireless telemetry. While Halo did not reach FIH testing within the project timeframe, its technical progress and new intellectual property pave the way for early human studies as part of the next phase of development.
The project also produced significant scientific contributions to the fields of cardiac implant design, tissue healing, and sensor technology. Results were presented at major international cardiology conferences (Heart Rhythm Society, TCT, CSI LAA) and are being prepared for publication in leading peer-reviewed journals. These efforts ensure that the knowledge gained from the project benefits the broader scientific and medical community.
From an economic and industrial perspective, ALLIANCE strengthened Europe’s position in advanced medical device manufacturing and innovation. AuriGen established partnerships with European suppliers for key implant and delivery components, ensuring a fully compliant ISO 13485 supply chain within the EU. The project also expanded AuriGen’s patent portfolio, securing protection for new device designs, anchoring methods, and sensor integration technologies in all major global markets.
At a societal level, the ALLIANCE Project contributes to Europe’s strategic goals of improving health outcomes and reducing healthcare costs through innovation. By enabling safer and more effective stroke prevention and paving the way for continuous cardiac monitoring, the project directly supports the EU’s objectives in digital health, ageing populations, and technological sovereignty. The technologies developed are expected to lower hospitalization rates, reduce dependence on long-term medication, and improve quality of life for patients across Europe and beyond.
In summary, the ALLIANCE Project successfully translated a groundbreaking idea, combining structural heart intervention with digital monitoring, into a validated clinical approach. The results demonstrate that European deep-tech innovation can directly address major global health challenges while strengthening the region’s industrial and scientific base. The work completed provides a clear pathway to regulatory approval, commercialization, and widespread clinical impact, positioning AuriGen and Europe at the forefront of next-generation cardiovascular care.
