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.

(PRNewsfoto/Affera, Inc.)

The work presented highlights:

  1. Safety and acute performance of Affera's focal Pulsed Field and RF Ablation solution in a 76 patient European multi-center study involving 11 operators.
  2. Multiple pre-clinical models demonstrating lesion durability as well as tissue specificity associated with pulsed field ablation
  3. Pulsed Field Mapping: an emerging mapping modality utilizing reversible electroporation

"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

  1. "Point-by-Point Pulsed Field Ablation (+/- Radiofrequency Ablation) to Treat Atrial Fibrillation: A First-in-Human Trial" by Vivek Reddy, Late-Breaking Clinical Trials - Innovation Boulevard

Scientific Peer-Reviewed Publications

  1. "A Lattice-Tip Focal Ablation Catheter that Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial," Vivek Reddy, et. al., Circulation EP
  2. "Pulsed-Field Ablation Using a Lattice Electrode for Focal Energy Delivery: Biophysical Characterization, Lesion Durability and Safety Evaluation," Elad Anter, et. al., Circulation EP
  3. "Focal Pulsed Field Ablation for Pulmonary Vein Isolation and Linear Atrial Lesions: A Preclinical Assessment of Safety and Durability," Jacob Koruth, et. al., Circulation EP

HRS 2020 Scientific Sessions

           Clinical Pulsed Field Ablation

  1. "Pulmonary Vein Isolation With Combination Of Radiofrequency And Pulse Field Energy Using A Novel Lattice Tip Electrode: A First In Human Trial" by Elad Anter, et. al., D-AB24-04
  2. "Safety Of A Combined Radiofrequency + Pulsed Field Ablation Approach To Pulmonary Vein Isolation In A First-in-human Clinical Trial" by Vivek Y. Reddy, et. al., D-PO01-126

    Clinical Radiofrequency Ablation

  3. "Catheter Ablation Of Scar-related Ventricular Tachycardia With A Novel Lattice Electrode Rf Ablation Catheter: A First In Human Clinical Trial" by Vivek Y. Reddy, et. al. D-PO01-130
  4. "Temperature-controlled Lattice-tip Ablation Catheter Improves Clinical Outcomes In Patients With Paroxysmal Atrial Fibrillation" by Mohit K. Turagam, et. al. D-PO02-183


  5. "First Preclinical And Clinical Demonstration Of Transient Myocardial Stunning / Reversible Electroporation With Pulsed Field Energy: A Novel Electrophysiological Maneuver" by Jacob S. Koruth, et. al. D-AB07-02
  6. "Rapid Confirmation Of Conduction Block Across Linear Ablation Lesions Using Real-time Propagation Vector Mapping In A Novel Expandable Lattice Radiofrequency Electrode Mapping/ablation System" by Hiroshi Nakagawa, et. al. D-PO01-140 

    Pre-Clinical Pulsed Field Ablation

  7. "A Lattice Tip Pulsed Field Ablation For Pulmonary Vein Isolation: Biophysical Characterization, Lesion Durability And Safety Evaluation" by Hagai Yavin, et. al. D-PO02-144
  8. "Durability And Safety Of Vein Isolation And Linear Atrial Lesions With Pulsed Field Ablation Using A 9mm Lattice-tip Catheter: A Preclinical Assessment" by Jacob S. Koruth, et. al. D-AB24-03
  9. "Preclinical Assessment Of Feasibility And Durability Of Mitral Isthmus Ablation Using Pulsed Field Ablation" by Kenji Kuroki, et. al. D-AB07-04
  10. "The Effect Of Pulsed Field Ablation On The Esophagus: A Preclinical Model Using A Novel Lattice Tip Catheter" by Hagai Yavin, et. al. D-PO04-149
  11. "Esophageal Effects Of Focal Pulsed Field Ablation Using A Novel Expandable Spherical Catheter" by Iwanari Kawamura, et. al. D-PO01-133
  12. "Is There Any Significant Thermal Effect During Focal Biphasic Pulse Field Ablation Of Atrial Tissue? - Insights From A Lattice-tip Catheter" by Kenji Kuroki, et. al. D-PO04-153

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.


Jordan Valley
Affera, Inc.

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