Periodic Reporting for period 4 - ABLAVIEW (An Innovative Image Guided Radiofrequency Ablation System to treat Atrial Fibrillation)
Berichtszeitraum: 2022-05-01 bis 2023-04-30
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.
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.
This project encompasses the optimisation of a 360-degree optical sensing coverage of catheter tip surroundings. This is achieved by miniaturised photonic components that direct and focus the light at 90 degrees, 45 degrees and forward-looking directions; fully covering the space around the device tip and enabling the multi-view catheter to provide real time information to the EP any catheter tip to tissue orientation.
The project structure starts with the System Integration featuring the Ablaview Catheter, Console and Software/GUI. That supposes the completion of the technical development of the first fully working prototype ready to conduct in-vitro and in-vivo work. The initial design and process development has been completed using the new platform in the tip, as well as the required changes in the catheter shaft and handle, allowing all the fibers being threaded and assembled properly.
Full system integration work has been performed allowing the different parts of the product to interface to each other to realize the tissue sensing functionality and meet the technical specification.
Pre-clinical functional verification was achieved through the creation of an in-vitro lesion library with the multifibre optical RF ablation catheter prototype. This in vitro lesion library established a robust relationship between proprietary real-time measurement of birefringence and the progression of the ablation lesion depth, which guided the EP’s during the first series of in vivo experiments that validated the in vitro model. These 2 steps are the basis of the Good Laboratory Practices experiments to be performed on a frozen-design catheter, console, and graphic user-interface design.
The project structure starts with the System Integration featuring the Ablaview Catheter, Console and Software/GUI. That supposes the completion of the technical development of the first fully working prototype ready to conduct in-vitro and in-vivo work. The initial design and process development has been completed using the new platform in the tip, as well as the required changes in the catheter shaft and handle, allowing all the fibers being threaded and assembled properly.
Full system integration work has been performed allowing the different parts of the product to interface to each other to realize the tissue sensing functionality and meet the technical specification.
Pre-clinical functional verification was achieved through the creation of an in-vitro lesion library with the multifibre optical RF ablation catheter prototype. This in vitro lesion library established a robust relationship between proprietary real-time measurement of birefringence and the progression of the ablation lesion depth, which guided the EP’s during the first series of in vivo experiments that validated the in vitro model. These 2 steps are the basis of the Good Laboratory Practices experiments to be performed on a frozen-design catheter, console, and graphic user-interface design.
AblaView is taking a breakthrough innovation further towards the market, by moving the concept from the current proof of principle stage to actual clinical validation. This is done by overcoming the technological disadvantages of current prototypes, incorporating more advanced OCT technology, and carrying out all the testing, documentation and manufacturing transfer activities needed to be ready for submission of the technical documentation to BSI, Medlumics Notified Body to begin clinical trials necessary for CE Certification of the AblaView System. The project represents an innovation that is of value globally but is especially relevant for the economic burden of treating AF within European healthcare systems.
AblaView represents a breakthrough solution in device-based arrhythmia management, improving acute and long term patient outcomes that become the standard of care for treating AF. The company will start clinical trials to demonstrate the safety and performance of AblaView, and ultimately its effectiveness in improving clinical practice. The work will involve patients to be recruited in European electrophysiology centres including 3-month and 1-year follow-up. These results, supported by prior preclinical work (in vitro laboratory model and animal experimentation) carried out with AblaView, will be the basis for filing for Class III Medical Device CE Mark, which will be the cornerstone of company value creation and commercialization plans.
The proposed activities in this project will take the AblaView from the TRL7 to TRL 9, with a complete and qualified system ready to reach the market in Europe by the end of the project.
AblaView represents a breakthrough solution in device-based arrhythmia management, improving acute and long term patient outcomes that become the standard of care for treating AF. The company will start clinical trials to demonstrate the safety and performance of AblaView, and ultimately its effectiveness in improving clinical practice. The work will involve patients to be recruited in European electrophysiology centres including 3-month and 1-year follow-up. These results, supported by prior preclinical work (in vitro laboratory model and animal experimentation) carried out with AblaView, will be the basis for filing for Class III Medical Device CE Mark, which will be the cornerstone of company value creation and commercialization plans.
The proposed activities in this project will take the AblaView from the TRL7 to TRL 9, with a complete and qualified system ready to reach the market in Europe by the end of the project.