First Patients Treated in MedLumics’ AblaView PFA System Trial

Ten patients have been treated thus far in MedLumics’ First in Man clinical trial evaluating its AblaView Unipolar Pulsed Field (PF) Ablation System, which features real-time fiber optic, visually guided atrial fibrillation (AF) ablation technology.

MedLumics’ AblaView catheter and control console with PF generator is intended to treat AF and other arrhythmias. All products for the study were designed, engineered, tested and manufactured at the MedLumics ISO 13485:2016 certified facility in Tres Cantos, Madrid (Spain).

MedLumics’ AblaView PF System allows for real-time confirmation of catheter-tip contact, visualization of optical changes in the tissue that predicts durable lesions, and identification of gaps in linear lesions using optical tissue signals. This Clinical Trial is ongoing and under protocol dictated follow-up.

“For the first time, we have real-time feedback on PFA lesion formation using optics. This is important since electrograms now have limited utility for durable lesion formation,” world-renowned cardiologist and cardiac electrophysiologist Atul Verma, M.D. of, McGill University Health Center, Montreal, Quebec, commented.

New CEO and board member Peter W. J. Hinchliffe, recently joined MedLumics to help guide the company to its clinical trial phase and eventual product commercialization. Hinchliffe has more than 40 years of experience in engineering and product development and is a highly accomplished and experienced medical device industry leader, having successfully built and led multi-disciplinary teams at Jarvik Heart, Getinge, DataScope, Rex Medical, United States Surgical Corporation (now Medtronic), driving key functions, including product development, manufacturing, quality assurance, regulatory approvals, marketing, and direct and distributor sales worldwide. With a strong engineering background, Hinchliffe has helped advance multi-billion dollar, multi-million dollar, and startup companies. His expertise spans a range of medical specialty devices. Hinchliffe holds more than 110 issued U.S. medical device patents and has over 100 still pending.

“I am impressed with the MedLumics development-focused teams and am excited to build and lead them forward,” Hinchliffe stated. “MedLumics’ AblaView optically guided ablation technology is truly revolutionary, enabling clinicians to finally see and confirm what they are doing in real time, visualizing 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.”

AF is the most common type of heart arrhythmia. An estimated 34 million people worldwide suffered from AF in 2010,¹ and prevalence of the disease is expected to increase as the number of people older than 65 continues to expand.^2,3 Although many technologies have emerged over the last several years to improve AF catheter ablation treatment, the ablation procedure has been elevated to first-line therapy in European Guidelines⁴ and in North American Guidelines,⁵ but outcomes remain difficult to predict. Broad registries reveal 60% recurrence rates at the one-year follow-up.⁶ The major and widely accepted cause of recurrence after initial successful ablation therapy is pulmonary vein reconnection due to interrupted and/or incomplete ablation line formation.

MedLumics’ FIM product, AblaView, is a catheter-based Pulsed Field ablation technology that optically guides catheter positioning and ablation treatment strategy using Optical Coherence Reflectometry (OCR). AblaView proprietary multibeam technology provides real-time, direct visual, confirmation of catheter contact, contact stability, and predicts lesion durability during tissue ablation, reducing recurrence rates and reducing procedure technical complexity while increasing procedural safety. 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 is currently focused on the AblaView PF catheter system and has a pipeline of additional target applications.

“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; next step will be to evaluate the three-month outcomes with remapping and optical check of the lesions,” MedLumics Vice President of Clinical and Regulatory Affairs Christophe Bailleul concluded.

Founded in 2014, MedLumics is an ISO13485 and ISO9001 certified medical device company specializing in optically guided medical devices. Its proprietary integrated optics platform technology combines optical and electrical components, enabling multi-view optically guided treatment with high-quality real-time images during cardiac ablation. MedLumics is backed by many public and private funds including an undisclosed corporate partner.

References
¹ Chugh SS, Havmoeller R, Narayanan K, et al.Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 study. Circulation 2014; 129:837–47.
² Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20.
³ Dai H, Zhang Q, Much AA, Maor E, Segev A, Beinart R, et al. Global, regional, and national prevalence, incidence, mortality, and risk factors for atrial fibrillation, 1990– 2017: results from the Global Burden of Disease Study 2017. Eur Heart J Qual Care Clin Outcomes 2021; 7:574–82.
⁴ Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).Eur Heart J. 2024 Sep 29;45(36):3314-3414.
⁵ Joglar JA, Chung MK, Armbruster AL et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jan 2;149(1):e1-e156.
⁶ Tzeis S, Gerstenfeld EP, Kalman J et al. 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation. J Interv Card Electrophysiol. 2024 Aug;67(5):921-1072.