RHYTHM AI announces FDA clearance of the commercial release version of STAR Apollo™ Mapping System
First-in-human cases successfully completed using this new system at Baptist Health, Jacksonville, Florida
London, 23rd September 2024: RHYTHM AI Ltd ("RHYTHM AI" or "the Company"), a UK company focused on optimizing Atrial Fibrillation (AF) procedures, announces US Food and Drug Administration (FDA) 510k clearance for the commercial launch version of its lead product, STAR Apollo™ Mapping System. The Company also reports the successful completion of first-in-human cases using the new system.
The new STAR Apollo Mapping System optimizes AF treatment with real time analysis of data from the LiveSync™ function of the EnSite™ X EP System (Abbott). STAR Apollo uses advanced AI driven algorithms, based on fundamental electrophysiological principles, to show repeating patterns within the arrythmia and identify regions of the heart that are potential drivers of AF. This allows the physician to create a customized treatment plan for each specific patient.
The Company also announces the successful completion of the first-in-human cases using the updated system by Dr Mathew McKillop, MD at Baptist Health, Jacksonville, Florida. Dr McKillop has wide experience of using the STAR Apollo Mapping System, having previously participated in an observational study using an earlier version of the product.
Dr Matthew McKillop, MD, FACC, FHRS, Clinical Cardiac Electrophysiologist and Medical Director, Electrophysiology Program, Baptist Health, Jacksonville, Florida commented: "STAR Apollo is allowing us to build tailored and targeted treatment strategies for this large patient group. It gives me unique insight into an individual's AF; I'm excited to use this new technology for my patients."
Simon Hubbert, Chief Executive of RHYTHM AI Ltd, commented: "We are delighted to announce the FDA clearance for the live stream version of STAR Apollo Mapping. This significant milestone, alongside continued support from our investors gives us the green light to bring to market a product that will deliver significant benefits during AF ablation procedures."
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RHYTHM AI Ltd Simon Hubbert, CEO | |
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About Atrial Fibrillation
Atrial Fibrillation (AF) is the commonest abnormal heart rhythm seen in clinical practice in which irregular electrical signals wander chaotically throughout the upper chambers (Atria) of the heart. AF affects an estimated 1.5 million in the UK and 4 to 6 million in the USA alone. The prevalence of AF has been projected to increase to 15.9 million by the year 2050.
AF is associated with significant clinical morbidity and is also an independent risk factor for mortality. Thromboembolic stroke is the most serious and debilitating of all the complications of AF. AF is also known to precipitate and worsen the outcomes of congestive heart failure.
Treatment of AF, and its associated complications, increases the use of healthcare resources and contributes to the ever-growing costs of healthcare, particularly costs associated with hospitalisations.
Catheter ablation is the most common and most effective treatment for AF, but has limited success in patients with persistent AF because of the erratic nature of AF. This makes it highly challenging to identify the exact cause or source of the AF. This means that even in experienced hands the first-time success rate is usually only around 50%.
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