MedLumics recently announced that 10 patients have been treated in the company’s first-in-man clinical trial, which is ongoing and currently under protocol-dictated follow-up. The AblaView unipolar pulsed field ablation (PFA) system used in this trial features MedLumics’ unique, real-time, fibreoptic, visually guided atrial fibrillation (AF) ablation technology.
A recent company press release notes that, with this announcement, MedLumics has officially entered the clinical development phase with its AblaView catheter and control console with PF generator, intended for the treatment of AF and other arrhythmias. MedLumics claims that its AblaView PFA system allows for real-time confirmation of catheter-tip contact, visualisation of optical changes in the tissue that predicts durable lesions, and identification of gaps in linear lesions using optical tissue signals.
“For the first time, we have real-time feedback on PFA lesion formation using optics,” said participating cardiologist and cardiac electrophysiologist Atul Verma (McGill University Health Center, Montreal, Canada). “This is important since electrograms now have limited utility for durable lesion formation.”
Christophe Bailleul, MedLumics’ vice president of Clinical and Regulatory Affairs, added: “After hundreds of animal investigations to develop and validate our PFA system, we could safely proceed to successful acute pulmonary veins isolations mainly using tissue optical properties in paroxysmal atrial fibrillation patients; [the] next step will be to evaluate the three-month outcomes with remapping and optical check of the lesions.”
In addition, Peter W J Hinchliffe recently joined MedLumics and its board of directors as the company’s new chief executive officer (CEO), with the goal of driving the company towards first-in-man data and beginning clinical-phase validation ahead of product commercialisation. A MedLumics press release notes that Hinchliffe brings more than 40 years of experience in engineering and product development, and is a highly accomplished and experienced leader in the medical device industry, having successfully built and led multidisciplinary teams at companies including Jarvik Heart, Getinge, DataScope, Rex Medical and United States Surgical Corporation (now Medtronic).
“I am impressed with the outstanding MedLumics development-focused teams, and am excited to build and lead them forward,” said Hinchliffe. “MedLumics’ unique AblaView optically guided ablation technology is truly revolutionary, enabling clinicians to finally see and confirm what they are doing in real time, visualising catheter tip position, confirming stable wall contact and delivering uninterrupted tissue ablation lines. Being able to differentiate treated and untreated tissue, and confirm treatments in real time, is new and truly addresses an unmet clinical need. The potential to reduce recurrence rates and provide a more reliable solution for the treatment of cardiac arrhythmias in today’s medical environment is critical to reducing overall healthcare costs.”
According to MedLumics, although AF patients are expected to benefit most from this innovation, AblaView is a platform technology with multiple therapeutic applications using AF ablation. The company also claims it is currently focused on the AblaView PFA catheter system and has a pipeline of additional target applications as well.
