MedLumics® Publishes FIM Results for AblaView® Ablation System in AF Patients
“We would like to extend our heartfelt thanks to the investigation site team, especially the investigators and proctors, for their invaluable contributions to this groundbreaking first-in-human trial. Their efforts have been crucial in enabling the publication of these important validating results,” said Peter Hinchliffe, CEO of MedLumics. “As we move forward, we are excited to announce our Series B funding round of €15 million, which will help us achieve our regulatory clinical trial readiness milestone. With these promising results, we are poised to advance toward treating the 100 million patients worldwide affected by Atrial Fibrillation.”
MedLumics® has made a significant breakthrough in the treatment of Atrial Fibrillation (AF) with the development of its AblaView® system, which enables real-time visualization during AF ablation treatments. This innovation is set to improve the precision, safety, and effectiveness of cardiac procedures by addressing key challenges faced by electrophysiologists. The AblaView® system utilizes advanced optical coherence reflectometry (OCR) to visualize critical factors during AF ablation and provide insights that were previously unattainable in real time. The system’s fiber-optic technology offers several unique capabilities that can enhance patient outcomes during the treatment of AF.
Key Features of MedLumics® AblaView® System
- Initial Heart Wall Contact Confirmation: One of the key challenges in AF ablation is ensuring that the catheter is in proper contact with the heart wall. MedLumics® AblaView® addresses this issue by enabling the differentiation between ablated and un-ablated tissue. This feature helps eliminate gaps in treatment lines, reducing the risk of incomplete ablation and preventing excessive ablation in non-targeted areas.
- Stable Electrode Wall Contact During Ablation: Achieving stable electrode contact with the heart wall is crucial for safe and effective ablation. The AblaView® system allows clinicians to monitor and maintain consistent contact throughout the procedure, which is essential to avoid complications such as hemolysis and neurovascular issues that can arise from poor electrode contact.
- Tissue Ablation Analysis in Real-Time: The AblaView® system provides real-time, optical imaging of tissue changes during ablation. Using optical coherence reflectometry (OCR), the system can directly visualize tissue birefringence (BiR) changes, which indicates whether irreversible lesions have been effectively delivered. This immediate feedback ensures that the ablation treatment is accurate, enhancing the procedure’s success rate.
AblaView® AF Ablation Results at Three Months
The results of a three-month follow-up on the use of the AblaView® system have shown promising outcomes:
- Safety and Reliability: The combination of real-time fiber-optic optical coherence reflectometry (OCR) and tissue birefringence (BiR) analysis has been shown to be both safe and reliable. This technique allows for real-time assessment of treated versus untreated tissue, confirming that lesions have been properly delivered while avoiding complications.
- No Hemolysis or Neurovascular Complications: The use of the AblaView® system’s optical imaging and real-time visualization significantly reduced the occurrence of complications associated with poor catheter contact and excessive ablations. Notably, there were no cases of hemolysis or neurovascular issues reported, highlighting the safety of the system.
- Durable Lesion Prediction with 100% Specificity: The AblaView® system’s ability to predict lesion durability in real-time has been validated with 100% specificity. This innovative feature allows electrophysiologists to predict the long-term effectiveness of the ablation immediately, ensuring better outcomes for patients and reducing the need for follow-up procedures.
Expert Opinions on AblaView® System
The results of this first-in-human study were presented at the AF Symposium in January and later published in Europace in February 2025. Several leading experts in the field of electrophysiology have expressed their enthusiasm about the potential of this technology.
Dr. Atul Verma, from the Electrophysiology Unit, Cardiology Department at McGill University, Montreal, Quebec, Canada, commented on the study, saying, “This first-in-human study demonstrates the ability of optics to determine durable lesions created by PFA. 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.”
Professor Raphael Martins, from the Cardiology Department at CHU Rennes, France, also praised the technology, stating, “It has been a privilege to take part in this first-in-human study. 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.”
In addition, Professor Sabine Ernst, MD, PhD, FESC, Consultant Cardiologist at the Royal Brompton and Harefield NHS Foundation Trust in London, expressed her excitement on LinkedIn, commenting, “Assessing the ablation lesion in real time: finally, the ‘holy grail’ in electrophysiology is discovered! A new era has begun!”
About MedLumics
Founded in 2014, MedLumics S.L. is an ISO 13485-certified medical device company focused on developing optically guided medical devices. The company’s proprietary integrated optics platform combines optical and electrical components, allowing for high-quality real-time imaging during cardiac ablation procedures. MedLumics is supported by various prestigious public and private funds, including an undisclosed corporate partner, and continues to drive innovation in the field of cardiac care.
The company’s commitment to advancing electrophysiology through optical technologies has the potential to revolutionize the way AF ablation is performed, enhancing safety, precision, and patient outcomes in this critical area of heart care.
