MedLumics has announced the publication of first-in-human results for the AblaView pulsed field ablation (PFA) system in atrial fibrillation (AF) patients, including clinical safety and the ability to predict durable lesions at three months with 100% specificity.
“We would like to thank the investigation site team and particularly the investigators and proctors in this groundbreaking first-in-human trial, and for enabling the publication of these important validating results,” said Peter Hinchliffe, chief executive officer (CEO) of MedLumics. “Join us as we raise our Series B funding of €15 million to reach our regulatory clinical trial readiness milestone. We are ready to move forward with these results toward treating the 100 million atrial fibrillation patients globally.”
According to the company, AblaView is able to visualise AF ablation treatments in real time, delivering initial heart wall contact confirmation, stable electrode wall contact during ablation, and tissue ablation analysis ‘as it happens’.
Three-month AF ablation results with the AblaView system—as reported in a MedLumics press release—are as follows:
- The use of AblaView fibre-optic, real-time optical coherence reflectometry (OCR), and assessing birefringence (BiR) of treated versus untreated tissue, is safe and reliable
- No haemolysis or neurovascular complications were reported, with the use of OCR and the AblaView PFA system’s real-time visualisation avoiding complications associated with poor contact quality and/or excessive ablations
- AblaView was able to measure the change in BiR to predict lesion durability, in real time, with 100% specificity
“This first-in-human study demonstrates the ability of optics to determine durable lesions created by PFA,” said Atul Verma (McGill University, Montreal, Canada). “These optical sensors can be adopted to any catheter platform and we will be moving forward with a full approval trial as the next step.”
After being presented by Verma at the 30th annual AF symposium (16–18 January 2025, Boston, USA), these study results have now been published in the journal Europace.
“It has been a privilege to take part in this first-in-human study,” commented Raphael Martins (CHU Rennes, Rennes, France). “The ability to assess lesion durability in real time using optical imaging may transform our approach to AF ablation. This represents a significant advancement toward more precise, safer and more effective treatments for our patients.”
