Atrial Fibrillation (AF) is characterized by an irregular and fast heart beat resulting in the uncoordinated contraction of the upper two chambers of the heart or “Atria”. AF is the most common type of cardiac arrhythmia affecting more than 37.6 million people worldwide representing 2-3% of the population diagnosed with AF. The prevalence of AF is expected to more than double within 30 years. AF is the most significant risk of stroke with people with AF having 5x greater risk of stroke.
The treatment goals for AF include regaining a normal heart rhythm and regulating the heart rate. Although commonly used, available drug therapies to control heart rhythm in AF have significant shortcomings, with more than half of patients’ refractory to treatment after one year. Antiarrhythmic compounds further suffer from serious side effects and reduced quality of life for patients, including pro-arrhythmic behaviour and non-cardiovascular toxicity. Cardiac ablation therapy called pulmonary vein isolation (PVI) isolates and prevents irregular electrical currents which occur mainly around the ostia of the pulmonary veins. Although catheter ablation is becoming a first-line therapy for some patients, the results are not yet fully satisfactory as 20% and 75% of patients have >2 recurrences of AF during the first and fifth year of after treatment, respectively. Success measured as freedom of AF at one-year follow up has been found to be as low as 41% in a broad European registry using multiple technologies. Additionally, patient safety is still a concern with this therapy; with serious adverse events being reported in 1 out of 40 patients. High recurrence rates requiring multiple ablation procedures or reliance on anti-arrhythmic drugs result in a huge financial burden representing a treatment cost of €660k - €3,286B annually across EU countries. Repeat ablations occur in 17% of patient for an incremental treatment cost of $40k per patient.
It is clear there is a large clinical and financial need to improvement ablation therapy by addressing the key factors which cause the recurrence of AF driving repeat procedures. Therapy success depends on the clinician’s ability to fully ablate tissue through the heart wall creating transmural lesions without perforation, called pericardial perfusion, or missing any gaps between ablation points that “ring-fence” or isolate the pulmonary veins resulting in electrical reconnections that cause AF recurrence. The fundamental building blocks for optimal AF ablation require realtime assessment of device tip to tissue contact, maintaining stable contact throughout the application of RF energy and being able to directly assess the progression lesion creation in terms of speed (safety) lesion depth prediction (efficacy), and all of this information presented clearly in real time to enable the clinician to make key decisions in real time. The current catheter ablation standard of care does not allow EP’s this level of direct visualization or real time therapy progression.
To address these clinical need, MedLumics has developed AblaView® which is a first optically guided radiofrequency (RF) ablation system for the treatment of AF. AblaView’s integrated optical sensor unblinds the procedure for the clinician allowing them to in realtime see catheter contact, orientation and stability in real time allowing for real time adjustments that improve safety and therapeutic outcomes. Ablaview uses biophotonic via the direction of infrared light into the tissue for treatment, Ablaview can accurately assess the speed and depth of ablation created in real time. AblaViews unique competitive advantage results in transmural lesions without the risk of over treatment to address efficacy and safety. Ablaview’s optical signal is both sensitive and specific allowing the EP to easily assess their ablation application to ensure no gaps exist and to identify and treat any gaps that do exist with precision to preserve precious myocardium.
