12.05.2020 22:19:00
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Affera's Technology for Cardiac Arrhythmia Treatment Highlighted at the 2020 Heart Rhythm Society Late-Breaking Clinical Trial Session and Three Simultaneous Publications
WATERTOWN, Mass., May 12, 2020 /PRNewswire/ -- Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today that its platform was featured prominently in scientific sessions at the Heart Rhythm Society 2020 (HRS) meeting held online May 6-9. Simultaneously, three manuscripts describing pre-clinical experiments and clinical trials with the company's Pulsed Field Ablation capability were published in Circulation: Arrhythmia and Electrophysiology.
The work presented highlights:
"Early this year, results from a 65-patient multi-center study of paroxysmal and persistent AF treated with our RF Ablation solution were published in JACC: Clinical Electrophysiology. This study demonstrated an unprecedented 99% durable PV isolation across 27 remapped patients and, more importantly, 94% 1-year freedom from any atrial arrhythmia," stated Doron Harlev, CEO and founder of Affera. "We have now extended our platform to include Pulsed Field Ablation, which was showcased at this HRS meeting along with additional innovations. We look forward to another exciting year as we continue to expand our efforts with the Sphere-9 catheter and beyond."
"Initial pre-clinical work delivering focal PFA with the Sphere-9 demonstrated lesion durability and the safety markers we expect from this non-thermal therapy modality," stated Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital. "These findings translated to exceptional safety and acute performance in a clinical setting. With one device we were able to easily and rapidly create effective RF and PF lesions for pulmonary vein isolation as well as lines of block on the mitral isthmus, roof, posterior box and cavo-tricuspid isthmus. This platform has the potential to transform the way AF therapy is delivered."
The following lists work presented:
Late-Breaking Clinical Trials
Scientific Peer-Reviewed Publications
HRS 2020 Scientific Sessions
Clinical Pulsed Field Ablation
Clinical Radiofrequency Ablation
Mapping
Pre-Clinical Pulsed Field Ablation
About Affera Inc.
Affera Inc. is a medical technology company dedicated to developing innovative solutions to address the rapidly growing field of cardiac arrhythmia treatment. 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 RF and PF 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 170 patients.
The Affera system is not currently approved for commercial use. For more information, please visit www.affera.com.
MEDIA CONTACT:
Jordan Valley
Affera, Inc.
857-304-4030
media@affera.com
www.affera.com
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SOURCE Affera, Inc.
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