CORDIS

Atrial fibrillation (AF), the most common heart-rhythm disorder is caused by abnormal electrical-activity in the heart;a quivering/irregular heartbeat(arrhythmia) that can lead to blood-clots,stroke,heart-failure and other complications.
AF Strokes are severe due to large clot-size formation;40% of patients having an AF stroke will die;40% will be severely disabled;only 20% will live a normal life compared with 80% recovery to a normal life for non-AF stroke-patients.
Everyday 1200 EU patients will have AF-related stroke,1600 will develop heart-failure and over 10million more will live in fear of every heartbeat.Treating these patients is expensive,costing EU & US health services over €100billion annually.In 2016,European AF patients spent 60million days in hospital.AF-patients are highly symptomatic and resistant to medication.There are 10.7 million AF patients across Europe and the US and 3.6 million of these patients are classified as having Persistent AF (PAF) and are living daily with threat of a heart attack/stroke . Standard surgical AF treatment is through catheter ablation,however for PAF patients,catheter-ablations work just 30% of the time, with many being repeated. The costs associated with managing PAF patients across the EU and US is >€100billion,escalating with aging populations. Patients, healthcare-providers and payers need more effective treatment. AuriGen addresses these needs.
Current solutions fall short: Catheter-ablation in the Left Atrial Appendage (LAA) has been successful in treating arrhythmia however increases blood clot formation in the LAA by 20%.LAA implants or “occlusion-devices” are new to the market and reduce dependence on anticoagulants.However it is not financially viable nor risk-appropriate for health services to fit occlusion-devices during the same procedure as LAA electrical isolation. Performing electrical isolation of the LAA in a patient who has already been fitted with an LAA occlusion-device is difficult and causes increased risk of short-term leaking and recurrence of AF.
The Aurigen Solution:A unique,minimally-invasive cardiac implant.Our technology provides electrical and mechanical LAA isolation in a one-shot procedure.This can treat both stroke and arrhythmia risk associated with PAF sufferers without increasing surgery length catheter-ablation procedures.
The objective of this project is to complete product & manufacturing-process development, pre-clinical & clinical studies, produce the Technical File for CE submission and market acceptance/adoption of the AuriGen device through a a well-executed market-access strategy.

The first reporting period 01/07/2018 to 30/06/2019 is comprised of work-packages(WP) 1,2,3,4&7 detailed below, and support product-development with focus on design,process & Regulatory strategy development.
WP1:produced a project-execution framework;project monitoring & control to achieve documented milestones,regular project meetings;technical reviews; project risk-assessment/mitigation; planning,risk-register; change-management, effective communication, collaboration and agile response to project demands.
WP2:generated;Quality&Regulatory plans outlining key-steps to navigating the US&EU regulatory pathways for pre-market approval, pre-clinical testing & the clinical study; Quality-Management-System & processes to support the regulatory pathway; Clinical-plan outlining approach to Clinical trials; Market Access plan.
WP3:iterative device prototype builds and development of bench-testing methods to verify performance, culminating in pre-clinical testing which demonstrated device capability;safe ablation of LAA target-zone;safe deployment of LAA implant; LAA image generation via the optical sensing element. Results demonstrated early safety and efficacy and facilitated C1 Design Review completion.
WP4:continued device design-development to further refine safety and efficacy. Prototype iterations were completed and verified by refinement of bench-testing methods and pre-clinical testing. Development of test-methods & equipment were progressed to support product-development and prepare for Design verification/validation activities and define challenge conditions for device safety & efficacy to reflect difficult clinical-cases.
WP7:activities to support market-access and product commercialization;appointment of key-personnel,health-economics assessment; company & product-profile development; through conference/exhibitions attendance &presentations, receiving industry-awards,press-releases and social-media activity.

The state-of-the-art is divided into devices which occlude/block the LAA (mitigate stroke-risk) and ablation-catheter therapy devices(restore normal heart-rhythm).LAA occlusion-devices are sub-categorized into 1) Minimally invasive intra-cardiac devices,placed by interventional-cardiologists &2)Epicardial-devices which close the LAA from outside the heart;deployed by cardio-thoracic surgeons (open-heart-surgery). Implantation-techniques are highly specialized,outside skill-sets of most interventional-cardiologists,must have a cardiologist and thoracic-surgeon present, and must be performed in specialist-cardiothoracic-centers, of which just 15-20 exist in the US, 2 in UK. Currently all devices are/have sought approval for AF-stroke-prevention and have not shown effectiveness treatment of AF arrhythmia.
AuriGen Benefits over State-of-the-Art:Environmental:Fewer procedures due to more effective treatment enable hospital energy-savings& hospital and patient travel emission reductions.Societal:Improved outcomes and quality-of-life for thousands of patients in Europe,USA and ultimately millions globally. AuriGen is the only fully percutaneous non-invasive device, enabling full electro-mechanical LAA isolation in one simple PAF procedure to reduce stroke-risk & address arrhythmia;increasing long-term procedural success from 28% to 56%min.
AuriGen device features exceed existing solutions; similar deployment to Watchman, facilitating rapid adoption; incorporation of RF-electrodes and oxygen-sensors is a unique confirmation of permanent electrical isolation for confidence in procedural success;enhanced implant safety;one-shot procedure shortens surgery and improves patient safety.
Expected Project-Results:Completion of commercialization activities including: Concept-Select/Design Freeze/Verification/Validation/Pre-Clinical/FIH evaluation/CE Approval/Commercialization/FDA Pivotal Trial
Impact: Initial CE mark focus on German,UK,Italian,French markets(66% of medical-device-sales in Europe), subsequent wider-adoption across EU(2022),US(FDA approval expected 2023) and worldwide.
Redo cardiac-ablations can cost €46K with approximately 72% of PAF patients requiring at least one redo; totaling €13.2billion in wasted healthcare-costs. The AuriGen device can reduce redo-procedures to 27% reducing healthcare costs to €5billion, a total-healthcare saving of €3.9 billion or >€9,750 saving-per-patient.Reimbursement codes for LAA Closure Therapy are in place.The electrical-therapy market is relatively new; valued over $3.6 billion, growing at 9-11% p.a.The global ablation market is predicted to double to $2.5 billion, through an increase in AF procedures(1million today to 1.7million by 2022). The US-Center-for-Disease-Control estimates the total US AF population is approximately 6million;10.2million in EU; projected to increase to an estimated 12million US cases 2030.P