Peter Hinchliffe, CEO of MedLumics, stated, “This marks a key milestone in validating a definitive Atrial Fibrillation (AF) ablation system, utilizing Pulsed Field Ablation (PFA) and Optical Coherence Reflectometry (OCR) to monitor and confirm ablation success in real-time under direct vision.”
MedLumics will present the results of its pivotal clinical study on the AblaView® optically guided Pulsed Field Ablation (PFA) system at the AF Symposium 2025 in Boston. The presentation, led by Dr. Atul Verma of McGill University, Montreal, Canada, will take place during the Late Breaking Clinical Science session on Friday, January 17th, 2025, from 5:30 to 7:00 PM EST.
The study was conducted at Ezgu Niyat Hospital in Tashkent, Uzbekistan, under the expert leadership of prominent proctors including Dr. Atul Verma, Prof. Raphael Martins from Rennes University Hospital, France, and Prof. Giorgi Papiashvili from the Israeli-Georgian Medical Research Clinic, Georgia. The principal investigator was Dr. Askar Sabirov, with Dr. Sherzod Sabirov serving as co-investigator. The trial was executed with the support of Clinical Accelerator Ltd. (CRO) and SMPEO Eurasia (SMO), completing in under four months.
Innovation in AF Ablation
MedLumics’ AblaView® system represents a significant advancement in the treatment of Atrial Fibrillation (AF), the most common type of heart arrhythmia. The system integrates Optical Coherence Reflectometry (OCR) with Pulsed Field Ablation (PFA) technology, providing real-time, direct visual confirmation of catheter contact, stability, and lesion durability. According to Prof. Martins, “Assessing lesion formation and transmurality using the AblaView system may help predict whether a PFA lesion will be durable or will reconduct. Analyzing the birefringence values can guide complementary lesion placement to improve durable pulmonary vein isolation (PVI) and sinus rhythm maintenance.”
Prof. Papiashvili from Tbilisi added, “The AblaView system, which incorporates real-time optical lesion assessment, can acutely determine the degree of tissue damage, leading to better lesion creation and more durable PVI.”
Addressing AF Challenges
AF affects an estimated 100 million people globally, and its prevalence is expected to rise as the population ages, with those over 65 being at the greatest risk. Despite advances in catheter ablation technologies, recurrence rates post-ablation remain high, with broad registries showing up to 60% recurrence at the one-year follow-up. A major cause of recurrence is pulmonary vein reconnection due to incomplete or interrupted ablation lines.
The AblaView® system aims to address this challenge by providing real-time feedback during the ablation process, which could reduce recurrence rates and improve procedural outcomes. The system’s multibeam optical technology allows clinicians to assess catheter contact and lesion quality, enhancing procedural accuracy and safety.
Platform Technology with Broader Applications
While AblaView® is designed primarily for AF ablation, it is a platform technology that holds potential for multiple therapeutic applications beyond AF. The system’s innovative use of PFA and OCR positions it for future expansion into other areas of cardiac and non-cardiac therapies.
About MedLumics
Founded in 2014, MedLumics is a ISO13485 and ISO9001 certified medical device company that specializes in optically guided technologies for medical applications. Its proprietary integrated optics platform combines optical and electrical components to deliver high-quality real-time imaging during procedures like cardiac ablation. MedLumics is supported by prestigious public and private investors, including an undisclosed corporate partner, and is committed to advancing patient care through optical guidance in medical treatments.