Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today that its focal Pulsed Field (“PF”) ablation technology, also known as Irreversible Electroporation (“IRE”), has been successfully used to treat 40 patients suffering from Atrial Fibrillation (“AFIB”).  This multi-center first-in-human study is designed to evaluate the safety and effectiveness of the Affera system and Sphere-9™ catheter using one of two treatment approaches in each patient: Focal PF ablation only or RF|PF, an optimized combination of focal PF and Radio Frequency (“RF”) ablation.  The patients were treated by six physicians at three centers including Vilnius University Hospital (PI: Gediminas Račkauskas), Lithuania as well as IKEM (PI: Josef Kautzner) and Homolka Hospital (PI: Petr Neužil) both in the Czech Republic. 

The expandable lattice tip of the company’s Sphere-9™ catheter and integrated Prism-1™ mapping and HexaGEN™ ablation system enable the rapid creation of detailed maps as well as the delivery of controlled, durable lesion sets in a variety of substrates. Designed to optimize procedural efficiency and efficacy across a broad range of cardiac arrhythmias, the system has been used to treat over 130 patients. 

Dr Andrea Natale

“Focal ablation has the advantage of allowing physicians to tailor the ablation lesions to patient-specific anatomy and physiology,” stated Andrea Natale, MD, Executive Medical Director of Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. “The stability of the Sphere-9 catheter coupled with the versatility of this focal ablation platform are an exciting combination.  I expect this platform to advance the field towards a new chapter in the safe and effective treatment of patients suffering from cardiac arrhythmia.”

Prof. Audrius Aidietis

Prof. Audrius Aidietis, MD, Head of Centre for Cardiology and Angiology at Vilnius University Hospital commented, “Following the extraordinary safety and efficacy outcomes with the first series of patients treated at our site with Affera’s RF technology, we were happy to perform the first cases extending this platform to include focal PF ablation.  We are pleased with the acute performance in these studies and look forward to future work together.”

Doron Harlev

“As part of our strong commitment to delivering the best outcomes for cardiac arrhythmia patients, we are pleased to add Focal Pulsed Field ablation capability to our platform,” stated Doron Harlev, CEO and founder of Affera. “Over 75% of all cardiac ablation procedures are performed with focal ablation tools and our team continues to lead innovation in this dominant category. We are excited by our initial results with focal PF as well as the safety benefits this emerging treatment modality may offer.”

In this first-in-human experience with Focal Pulsed Field ablation, a variety of AF-related ablation lesion sets were effectively employed including not only pulmonary vein isolation, but also linear ablation of the left atrial roof, mitral isthmus and cavo-tricuspid isthmus where needed.  No device related adverse events have been reported.

AFIB, or an irregular heartbeat, is a condition which can lead to blood clots, stroke, heart failure and other heart-related complications.  With an estimated 33 million people worldwide currently living under the condition, 1 in 4 adults over 40 is at risk of developing AFIB in their lifetime. 



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