"This is a key milestone in validating a definitive Atrial Fibrillation (AF) ablation system using PFA and Optical Coherence Reflectometry (OCR) to monitor and confirm the success of ablation under direct vision in real time" Peter Hinchliffe, CEO MedLumics
The results of this clinical investigation will be presented in Boston at the AF Symposium 2025 by Dr. Atul Verma of McGill University, Montreal, Québec, Canada, during the Late Breaking Clinical Science session on Friday January 17th, 2025 (5:30 7:00pm EST).
"The study took place at Ezgu Niyat Hospital, Tashkent, Uzbekistan under the expert leadership of our proctors Dr. Atul Verma, Prof. Raphael Martins (Rennes University Hospital, Rennes, France), Prof. Giorgi Papiashvili (Israeli-Georgian Medical Research Clinic Healthycore, European University, Tbilisi, Georgia), with the Principal Investigator Dr. Askar Sabirov and co-PI Dr. Sherzod Sabirov." Christophe Bailleul, VP Clinical and Regulatory, MedLumics
"The trial was executed locally with the support of the CRO, Clinical Accelerator Ltd. and the SMO SMPEO Eurasia, within less than 4 months." David Herranz, Clinical Manager, MedLumics.
Prof. Martin from Rennes, France attended both the ablations in September and the remapping in December, commented; "Assessing lesion formation and transmurality using the AblaView system may definitely help to predict whether a PFA lesion will be durable or will reconduct. Analyzing the Birefringence values may then help decide whether complementary lesions should be performed, aiming at improving durable PVI, and consequently sinus rhythm maintenance"
After the remapping session Prof. Papiashvili from Tbilisi, Georgia added that "The technology for catheter ablation of atrial fibrillation has improved dramatically but still achieving durable PVI remains a challenge. The AblaView incorporates a real time optical lesion assessment based on a loss of tissue birefringence. The system seems to be able to acutely determine the degree of tissue damage which should lead to better lesion creation and a durable PVI."
AF is the most common type of heart arrhythmia. An estimated 100 million people worldwide currently suffer from AFi, and prevalence of the disease is expected to increase as the number of people over the age of 65 continues to expandii, since the greatest risk factor is age.iii Although many technologies have emerged over the last several years to improve the catheter ablation treatment of AF, the ablation procedure has been elevated to 1st line therapy in European Guidelinesiv and in North American Guidelinesv, but outcomes remain difficult to predict. Broad registries reveal recurrence rates of up to 60 percent at the one-year follow-up time pointvi. The major and widely accepted cause of recurrence after initially successful ablation therapy is pulmonary vein reconnection due to interrupted and/or incomplete ablation line formation.
MedLumics' FIM product, AblaView, is a catheter-based PFA technology that optically guides catheter positioning and ablation treatment strategy using OCR. AblaView proprietary multibeam technology provides real-time, direct visual, confirmation of catheter contact, contact stability, and predicts lesion durability during tissue ablation, with the potential to reduce recurrence rates and reduce procedure technical complexity while increasing procedural safety. Although AF patients are expected to benefit most from this innovation, AblaView is a platform technology with multiple therapeutic applications using OCR and PF ablation. The company is currently focused on the AblaView PFA catheter system for AF Ablation and has a pipeline of additional target applications.
About MedLumics
Founded in 2014, MedLumics is an ISO13485 and ISO9001 certified medical device company specializing in optically guided medical devices. Its proprietary integrated optics platform technology combines optical and electrical components, enabling multi-view optically guided treatment with high-quality real-time images during cardiac ablation. MedLumics is backed by many prestigious public and private funds including an undisclosed corporate partner. For more information visit www.medlumics.com.
The Ablaview® system is investigational and not currently available for commercial use.
i Wong CX, Tse HF, Choi EK, et al. The burden of atrial fibrillation in the Asia-Pacific region. Nat Rev Cardiol. 2024 Dec;21(12):841-843.
ii Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20.
iii Dai H, Zhang Q, Much AA, Maor E, Segev A, Beinart R, et al. Global, regional, and national prevalence, incidence, mortality, and risk factors for atrial fibrillation, 1990- 2017: results from the Global Burden of Disease Study 2017. Eur Heart J Qual Care Clin Outcomes 2021; 7:574-82.
iv Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).Eur Heart J. 2024 Sep 29;45(36):3314-3414.
v Joglar JA, Chung MK, Armbruster AL et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jan 2;149(1):e1-e156.
vi Tzeis S, Gerstenfeld EP, Kalman J et al. 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation.J Interv Card Electrophysiol. 2024 Aug;67(5):921-1072.
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Contacts:
Media contact; Lucia Colmenero (+34) 91 803 39 25 info@medlumics.com
