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:
- 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.
- Multiple pre-clinical models demonstrating lesion durability as
well as tissue specificity associated with pulsed field
ablation
- 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
- "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
- "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
- "Pulsed-Field Ablation Using a Lattice Electrode for Focal
Energy Delivery: Biophysical Characterization, Lesion Durability
and Safety Evaluation," Elad Anter,
et. al., Circulation EP
- "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
- "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
- "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
- "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
- "Temperature-controlled Lattice-tip Ablation Catheter Improves
Clinical Outcomes In Patients With Paroxysmal Atrial Fibrillation"
by Mohit K. Turagam, et. al. D-PO02-183
Mapping
- "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
- "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
- "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
- "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
- "Preclinical Assessment Of Feasibility And Durability Of Mitral
Isthmus Ablation Using Pulsed Field Ablation" by Kenji Kuroki, et. al. D-AB07-04
- "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
- "Esophageal Effects Of Focal Pulsed Field Ablation Using A
Novel Expandable Spherical Catheter" by Iwanari Kawamura, et. al.
D-PO01-133
- "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.
MEDIA CONTACT:
Jordan Valley
Affera, Inc.
857-304-4030
media@affera.com
www.affera.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/afferas-technology-for-cardiac-arrhythmia-treatment-highlighted-at-the-2020-heart-rhythm-society-late-breaking-clinical-trial-session-and-three-simultaneous-publications-301058049.html
SOURCE Affera, Inc.