Project description
Cardiac implant for the treatment of stroke and arrhythmia
Atrial fibrillation (AF) is a condition characterised by irregular heartbeat caused by abnormal electrical activity that can lead to blood clots, stroke and heart failure. Millions of AF patients across Europe and the United States suffer from persistent AF (PAF), which is medication-resistant. Surgical electrical therapy destroys the heart tissue that causes the abnormal electrical pulses, but for PAF patients, this works only 30 % of the time. Irish AuriGen Medical has developed a minimally invasive cardiac implant that permanently isolates the left atrial appendage electrically and mechanically, treating both the stroke and arrhythmia risk associated with PAF with no increase in surgery time. The EU-funded LAA-START project will carry out clinical studies for safety and efficacy to complete product development as per the regulatory guidelines for medical devices.
Objective
Atrial Fibrillation (AF) is an irregular heartbeat caused by abnormal electrical activity in the heart, that can lead to blood clots with high risk of stroke and heart failure.
There are 10.7 million AF patients across Europe and the US, 3.6 million are classified as having Persistent AF (PAF), they are highly symptomatic and medication resistant. Surgical electrical therapy (catheter ablation) destroys heart tissue causing the abnormal electrical pulses. For PAF patients, this works only 30% of the time. Approximately 72% of PAF patients require at least one redo procedure, amounting to €13.5 billion in wasted healthcare costs.
Success rates are doubled if electrical activity in a part of the heart “the Left Atrial Appendage” (LAA), is shut down. But this increases stroke risk from blood clots as the LAA is now incapable of muscle contraction to maintain blood flow.
LAA implants, “occlusion devices” fit across the opening of the LAA to filter the blood and prevent clots from entering the blood stream. However, fitting an occlusion device during the same procedure as LAA electrical isolation doubles procedure time (to 7 hours) making it non-financially viable for health services and too high risk for patients.
AuriGen Medical have developed a unique, minimally invasive cardiac implant which permanently electrically and mechanically isolates the LAA in a one-shot procedure: treating both the stroke and arrhythmia risk associated with PAF with no increase in surgery time.
This multi-partner FTI project will complete product development in line with the regulatory development pathway for medical devices for first in human safety and efficacy clinical studies required for CE certification and contributing to FDA clinical data requirements. The total market opportunity is $5bn/yr market opportunity across the EU and US. AuriGen will enter the market directly in the initial target European markets (Germany, France, Italy and UK) during Q3 2020.
Fields of science
- medical and health sciencesclinical medicinecardiologycardiovascular diseasescardiac arrhythmia
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- medical and health sciencesbasic medicineneurologydementia
- medical and health sciencesbasic medicineneurologystroke
- medical and health sciencesmedical biotechnologyimplants
Programme(s)
Funding Scheme
IA - Innovation actionCoordinator
DUBLIN 13 Dublin
Ireland
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.