MedLumics New CEO and Board Member Announces 10 Patients Treated in First in Man (FIM) Clinical Trial With the Real-Time Visually Guided AblaView PFA System
MADRID–(BUSINESS WIRE)– MedLumics, a medical device company developing fiber optically guided platform technologies for the treatment, initially, of Atrial fibrillation (AF), announced today 10 patients treated in the company’s First in Man clinical trial. The AblaView Unipolar Pulsed Field (PF) Ablation System, used in this trial, features MedLumics unique, real-time, fiber optic, visually guided AF ablation technology. MedLumics officially enters the clinical development phase with its AblaView catheter and control console with PF generator, intended for the treatment of AF and other arrhythmias. All product for this clinical trial were designed, engineered, tested and manufactured at the MedLumics ISO 13485:2016 certified state of the art facility in Tres Cantos, Madrid.
First in Man (FIM) – MedLumics AblaView PF System has been used to treat 10 patients in a clinical trial. The system allows for real-time confirmation of catheter-tip contact, visualization of optical changes in the tissue that predicts durable lesions, and to identify gaps in linear lesions using optical tissue signals. This Clinical Trial is ongoing and under protocol dictated follow-up.
Participating world-renowned cardiologist and cardiac electrophysiologist Atul Verma, MD of, McGill University Health Center, Montreal, Quebec, commented, “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.” Christophe Bailleul, VP Clinical and Regulatory Affairs, commented, “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 3-month outcomes with remapping and optical check of the lesions.”
New CEO and Board Member, Peter W. J. Hinchliffe, recently joined MedLumics and the board of directors, to drive the company to FIM, beginning the clinical phase validation toward product commercialization. Mr. Hinchliffe brings over 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 multi-disciplinary teams at companies including: 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 around the world. With a strong engineering background, Peter has been involved in the advancement of multi-billion dollar, multi-million dollar, and start-up companies. His expertise spans a range of medical specialty devices. He holds over 110 issued US medical device patents and has more than 100 still pending.
“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, visualizing catheter tip position, confirming stable wall contact and delivering uninterrupted tissue ablation lines.” Hinchliffe continued, “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 20101, and prevalence of the disease is expected to increase as the number of people over the age of 65 continues to expand2.3 Although many technologies have emerged over the last several years to improve the catheter ablation treatment of AF, the ablation procedure has been elevated to 1st line therapy in European Guidelines4 and in North American Guidelines5, but outcomes remain difficult to predict. Broad registries reveal recurrence rates of up to 60 percent at the one-year follow-up time point6. The major and widely accepted cause of recurrence after initially 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 (PF) 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.
About MedLumics
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 prestigious public and private funds including an undisclosed corporate partner. For more information, visit www.medlumics.com.
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.
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Contacts
Media: Lucia Colmenero (+34) 91 803 39 25 info@medlumics.com