Atrial Fibrillation (AFib) is a debilitating and life-threatening condition with a high and increasing prevalence worldwide. The irregular heart-beat of AF causes the patient to have palpitations, weakness, fatigue and dizziness. In addition, patients with AFib are five times more likely to have a stroke due to the formation of clots. However current treatments have low success rates and have significant risks and complications. Moreover, the most widely used treatment – cardiac ablation - still has limited adoption with the majority of patients hesitant to be treated knowing the potential for poor outcomes and complications. Between 20-40% of patients that receive a cardiac ablation will need a repeat treatment after 2-3 years.
The economic burden of atrial fibrillation is substantial – it is estimated that approximately 2.6% of all healthcare expenditure in Europe is spent on AFib. The annual cost of dealing with stoke that originates from AFib is estimated to be €45 billion a year in the EU.
AtriAN Medical is bringing a revolutionary treatment to market that is the first to specifically target the autonomic origin of the signal that causes AFib, thus eliminating the arrhythmia early and preventing disease progression. In addition to increased success rates, the AtriAN technology will reduce the risk of complications and the procedure will be done in a fraction of the time needed for current treatments; approximately 2 hours compared to 6-8 hours.
AtriAN's technology uses specialized catheters delivering short pulses of low energy electrical fields to discrete sites of autonomic hyperactive nerves located on the outside surface of the heart. This pulsed electric field selectively ablates these autonomic nerve structures, providing a long-term resolution to AFib. The treatment may be used as a stand-alone approach in certain patients or can be used in conjunction with conventional treatments to improve outcomes.
The overall objective of the Neuron-AFib project was to complete a first-in-human (FIH) trial to evaluate this technology; to provide data on safety and feasibility data. This trial was successfully completed with safety and feasibility data obtained for 24 patients as well as promising acute measures of longer term efficacy. This now enables AtriAN to progress to further trials in order to get regulatory approvals for sale of the device in Europe and the US. In parallel with the FIH trial development on a next generation of the device, for minimally invasive access, was also performed.
