MedLumics Celebrates a Major Breakthrough: Successful Completion of the FIM Study for Cutting-Edge AF Ablation Technology
2024-12-19
Author: Charlotte
MADRID — MedLumics is thrilled to announce the successful completion of its First-in-Man (FIM) clinical study, which indicates the efficacy of their innovative AblaView® Optically Guided Pulsed Field Ablation (PFA) System for treating Atrial Fibrillation (AF). Peter Hinchliffe, the CEO of MedLumics, highlighted that “This is a key milestone in validating a definitive AF ablation system. Our technology utilizes PFA alongside Optical Coherence Reflectometry (OCR), providing real-time monitoring to ensure ablation success under direct visualization.”
The promising results of this study will be showcased by Dr. Atul Verma from McGill University during the prestigious AF Symposium 2025 in Boston on January 17th, as part of the Late Breaking Clinical Science session.
Conducted at Ezgu Niyat Hospital in Tashkent, Uzbekistan, the study involved a seasoned team of experts including Prof. Raphael Martins from Rennes University Hospital and Prof. Giorgi Papiashvili from Healthycore, among others. "The trial was executed within less than four months under the capable supervision of our principal investigators, Dr. Askar Sabirov, and co-investigator Dr. Sherzod Sabirov," noted David Herranz, Clinical Manager at MedLumics.
The feedback from physicians involved in the study underscored the potential of the AblaView system in predicting lesion durability, which is critical for ensuring long-term success in AF treatment. Prof. Martins remarked, "Assessing lesion formation and transmurality using the AblaView system may help predict whether an ablation lesion will be durable or prone to reconduction." Similarly, Prof. Papiashvili emphasized how advancements in catheter ablation technology are shaping the future of AF treatment: "Real-time optical assessment of lesions allows for better quality control in ablation procedures."
Atrial Fibrillation is the most prevalent heart arrhythmia globally, affecting an estimated 100 million people. With age being a significant risk factor for AF, the condition's prevalence is projected to rise, posing challenges for effective management. Current strategies for catheter ablation have made significant strides; however, the recurrence rates remain high, with studies showing as much as a 60% chance of recurrence within a year. These recurrences are often attributed to pulmonary vein reconnection, an area in which the AblaView technology aims to make impactful improvements.
The AblaView system leverages its proprietary multibeam technology to provide real-time visual feedback during catheter positioning and ablation, thereby enhancing procedural safety and efficiency. Although primarily aimed at improving AF patient outcomes, the technology holds promise for broader therapeutic applications, thus expanding the potential impact on cardiac care.
Founded in 2014, MedLumics is dedicated to pioneering medical devices guided by optical technology, holding a strong track record backed by numerous esteemed investors and partnerships. As the healthcare landscape continues to evolve, innovations like the AblaView system could redefine standards for AF treatment.
The AblaView® system is currently investigational and not available for commercial use. However, its introduction marks a hopeful step forward in the fight against Atrial Fibrillation, heralding an era of enhanced care for millions worldwide. For updates on their groundbreaking work, visit www.medlumics.com.