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Recently, the term “pulsed field ablation” has been used to describe nonthermal monophasic- or biphasic-waveform, field-based cardiac arrhythmia ablation. Objective: The purpose of this study was to compare duty-cycled radiofrequency ablation (RFA) to pulsed field ablation (PFA) in terms of acute electrical effects, 2-week lesion formation, and injury to nontargeted tissues. Farapulse is sponsoring the ADVENT randomized trial of the Farapulse PFA system and Medtronic launched the international PULSED AF trial of its PulseSelect PFA system. Heart Rhythm Sessions. Pulsed‐field ablation (PFA) is a promising new ablation modality for the treatment of atrial fibrillation. Vision-MR Ablation Catheter Receives CE Mark. al., Circulation E 8113 national drybean drought yield trial 6/4/2018 svrec 32 alpha lattice 3 direct 8214 standard kidney bean yield trial 6/12/2018 mrf 56 rec. 27,29–31 Each therapeutic application consists of a series of electric pulses delivered as a pulse train. Excited to announce initial clinical work with Focal Pulsed Field ablation using the Affera system! This multi-center first-in-human study is … AFFERA – CP-00003 Assessment of the safety and performance of the Ablation Catheter and Sphere-9 ™ Atrial Arrhythmia Mapping and Ablation System. 2021 Western A-Fib Symposium Faculty Roster. The one-shot technologies, particularly pulsed-field ablation, are promising, but by definition, are largely limited to only ablating PVs. 92 Pulsed Field Ablation for Pulmonary Vein Isolation: Lesion Durability and Chronic Safety Neužil P, Petrů J, Královec Š, Minami K, Funasako M, Baroch J, Reddy V Kardiologické oddělení Nemocnice Na Homolce Praha, Praha, ČR 10 Affera, Atrian, CardioNXT, Kardium, LuxMed, and we should not be surprised if there will be some more. 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. Enrolled patients will then undergo ablation using the FARAPULSE Endocardial Ablation System. In the meantime, you can access the participating faculty list and full scientific program from last year’s AF Symposium for an example of … Reddy Vivek Y., Anter Elad, Rackauskas Gediminas, et al. A new clinical trial effectively uses pulsed field (PF) energy to treat patients with persistent or paroxysmal atrial fibrillation (AF) and showcases a novel approach to performing point-by-point ablation to provide safe and effective patient outcomes. Watertown, Massachusetts, 02472, United States. For example, ablation systems of the present disclosure can allow for the flow of irrigation fluid and blood through an expandable ablation electrode, resulting in efficient and effective cooling of the ablation electrode as the ablation electrode delivers energy at a treatment site of the patient. This prospective, international, single-arm investigation was presented virtually as a late-breaking clinical trial during the Annual Scientific Sessions of the Heart … Pulsed Field Ablation Makes Waves at AF Symposium. A novel lattice-tip focal ablation catheter (Affera Inc.) shows promise for combining the best aspects of pulsed-field ablation (PFA) and radiofrequency ablation (RFA) for treatment of atrial fibrillation (AF), according to a first-in-human study. 10x Genomics, Inc. (TXG) 23andMe, Inc. 3M (MMM) 480 Biomedical, Inc. 77 Elektronika Kft. In some embodiments, an apparatus includes a voltage pulse generator and an electrode controller. Pulsed Electrical Field Ablation for PVI: Preclinical and Clinical Experience. Work. This energy form employs a train of microsecond duration high amplitude electrical pulses that ablate myocardium by electroporation of the sarcolemmal membrane without measurable tissue heating. Toggling between energy sources, point by point, pulmonary vein [PV] encirclement was performed using biphasic pulsed field ablation, posteriorly, and either temperature controlled irrigated RFA or pulse field ablation, anteriorly (RF/PF or PF/PF) respectively. Subjects will be followed at 7 days, 30 days, 75 days, 6 months, and 12 months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 3 months following the PEF (pulsed electric field) catheter ablation procedure. Talk to an Expert. Join now to see all activity state of the art in the field of atrial fibrillation in a scholarly and collegial atmosphere, as well as an opportunity ... Affera – Vivek Reddy, MD CardioNXT – Subbarao Choudry, MD ... Update on Balloon Technologies for AF Ablation Karl-Heinz Kuck, MD Pulsed Electrical Field Ablation for PVI: Preclinical and Clinical Experience Excited to announce initial clinical work with Focal Pulsed Field ablation using the Affera system! I’ve posted a new report about an ablation for a patient with persistent A-Fib who had been cardioverted and was now in Atrial Flutter. Pulsed AF: First Human Experience And Acute Procedural Outcomes Using A Novel Pulsed Field Ablation System. 2019. 44 Pleasant St Suite 200. My next report from the 2021 AF Symposium is on the short side. 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. Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced 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 … The first-in-human trial combines the effectiveness of radiofrequency (RF) energy with the safety of pulsed field energy for ablation procedures. Focal PFA Our experimental model is a Langendorff-perfused … Education. Ablation systems and methods of the present disclosure are directed toward delivering pulsed radiofrequency (RF) energy to target tissue. Methods: Intracardiac ablations were performed in 6 pigs using a circular pulmonary vein ablation catheter. The AFFERA system. WATERTOWN, Mass., Dec. 19, 2019 /PRNewswire/ — 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”). Pulsed Field Ablation (PFA) is a revolution in the safety and speed of catheter ablation , and will render a lot of surgical ablation obsolete. #epeeps https://lnkd.in/eQKYquB Liked by Michael Friedman. Drs. #epeeps https://lnkd.in/eQKYquB . Two pivotal US trials of pulsed field ablation systems began in early March. A novel lattice-tip focal ablation catheter (Affera Inc.) shows promise for combining the best aspects of pulsed-field ablation (PFA) and radiofrequency ablation (RFA) for treatment of atrial fibrillation, according to a first-in-human study. Background: Pulsed field ablation (PFA) is a nonthermal energy that may provide safety advantages over radiofrequency ablation (RFA). Among the cohort, 40 patients had radiofrequency ablation anteriorly and pulsed field ablation posteriorly (RF/PF) and the rest had pulsed field ablation anteriorly and posteriorly (PF/PF). • Novel ablation- Ultra-short, high-voltage electrical impulses • Large increase in the electric field across cell membrane - Nanoscale pores • Specific thresholds for target tissue • Permanent nanopores - Cell death Expert Rev Cardiovasc Ther. (RF Ablation) HexaPulse (Pulsed Field Ablation) HexaMap RF/PF Ablation System (HexaGen and HxaPulse, Affera, Inc) 9 mm 8 Fr Deflectable Catheter, Expandable Lattice Tip Electrode Catheter (Sphere-9, Affera, Inc) 9 Mini-Surface Electrodes and 9 Thermo-Couples Central Reference Electrode (“No Tissue Contact”) Central Lumen for Saline Irrigation J. 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”). Latest From Affera, Inc. Medtronic, Farapulse Advance Pulsed Field Ablation With US Trials Bookmark 11 Mar 2021; News; By Reed Miller. #epeeps https://lnkd.in/eQKYquB 1: Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, 2: Division of Epidemiology, Kobe University Graduate School of Medicine, Kobe. FDA Trial (ADVENT) Ongoing. FDA Perspective: How to Balance Patient Safety, Regulatory Requirements and the Need for Innovation to Advance Patient Care in AF Ablation. Abstract Pulsed-field ablation (PFA) is a promising new ablation modality for the treatment of atrial fibrillation. The AFFERA system uses a single lattice-tip catheter but two different energy generators, one for PFA and another for RF ablations. über die ersten klinischen Erfahrungen mit dem Affera-System (Affera, Inc., Watertown, MA, USA) und dem Lattice-Tip RF-Ablationskatheter . Multiple pre-clinical models demonstrating lesion durability as well as tissue specificity associated with pulsed field ablation How well the minielectrodes perform is also unknown. An innovative engineer and troubleshooter working at Affera, a startup developing a novel ablation system to treat heart rhythm disorders. Affera, 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 … Cardiologist Finds Signs of Atherosclerosis in Mummified Ancient Greenlanders. I previously received my Master of Science in Mechanical Engineering from Carnegie Mellon University in May 2016. Update on Balloon Technologies for AF Ablation. Multiple pre-clinical models demonstrating lesion durability as well as tissue specificity associated with pulsed field ablation. ... Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. 3:30-4 PM: Break and Exhibits The Affera Inc. pulsed field (PF) energy radiofrequency ablation system. The pulsed-field ablation deliveries produced larger EGM amplitude reductions than phased RF and more frequently produced transmural lesions and contiguous lesions with fewer sequestered viable myocytes than phased RF. Heart Rhythm Sessions 2019. Linear lesions were created with either PFA or RFA. 2018 May;16(5):349-360, Chang D.C., and Reese T.S.. Technical Consultant for Cardiac Ablation Solutions at Medtronic Gloucester, United Kingdom 32 connections. The Pulmonary Vein Ablation Catheter GOLD (PVAC™ GOLD) is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic atrial fibrillation (AF). Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. This study investigated a novel lattice-tip catheter designed for focal RFA or PFA ablation. Report Library. The voltage pulse generator is configured to produce a pulsed voltage waveform. The novel Sphere-9 catheter (Affera) has an expandable spheroid-shaped lattice tip with a 10-fold larger effective area compared to the conventional 3.5 mm electrode. For your reference, all faculty and planners are listed below with their contact information, as it is received and authorized for release. Lattice-Tip: RF/PF. „Pulsed field ablation“ ... weiteren „late breaking clinical trial“ berichteten Reddy et al. Excited to announce initial clinical work with Focal Pulsed Field ablation using the Affera system! FIELD OF THE INVENTION. 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. Luke Tsai. siderable interest is pulsed field ablation (PFA) because preclinical studies have indicated that it can preferen-tially ablate myocardial tissue.11–16 The myocardium has a higher sensitivity to pulsed electrical fields than other tissues.17 Indeed, using a multielectrode PFA catheter, we recently demonstrated that PVs could be electrically However, there is increasing awareness that other LA ablation lesions, such as MI and LA roof lines, may be important to improving the success of PerAF ablation ( 13 ). WATERTOWN, Mass., Dec. 19, 2019 /PRNewswire/ -- 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"). New Lattice Catheter – Combination Irreversible Electroporation and Pulsed Field Ablation. The AFFERA system uses a single lattice-tip catheter but two different energy generators, one for PFA and another for RF ablations. CorMatrix announces the first minimally invasive robotic implant. doi:10.1161/ CIRCEP.120.008718 Pulsed Field Ablation. Reddy and Neuzil demonstrated a new, innovate strategy of using Pulsed Field Ablation (PFA) combined with RF ablation developed by AFFERA, Inc. Pulsed field ablation (PFA) is a nonthermal energy that may provide safety advantages over radiofrequency ablation (RFA). The paper provides a biophysical characterization of the Affera… One of the great advantages of Pulsed Field Ablation (PFA) is that the PF energy doesn’t damage adjacent tissue or structures such as the Phrenic nerve or the esophagus. Listing a study does not mean it has been evaluated by the U.S. Federal Government. The Affera system will therefore have to demonstrate similar effectiveness and safety to be competitive. Ablation of Cardiac Tissue with Nanosecond Pulsed Electric Fields: Experiments and Numerical Simulations Fei Xie ... electric field which leads in cardiac tissue and helps to provide a guideline for clinical tissue ablation. A novel lattice-tip focal ablation catheter (Affera Inc.) shows promise for combining the best aspects of pulsed-field ablation (PFA) and radiofrequency ablation (RFA) for treatment of atrial fibrillation, according to a first-in-human study. The first-in-human trial combines the effectiveness of radiofrequency (RF) energy with the safety of pulsed field energy for ablation procedures. One of the great advantages of Pulsed Field Ablation (PFA) is that the PF energy doesn’t damage adjacent tissue or structures such as the Phrenic nerve or the esophagus. Atul Verma, MD, FHRS, Southlake Regional Health Center, Toronto, ON, Canada Point-by-point Pulsed Field Ablation (+/- Radiofrequency Ablation) To … It can deliver higher energy with a lower risk of tissue overheating. Pulsed field ablation continues to look promising for atrial fibrillation in early results, researchers reported in two studies at the virtual Heart Rhythm Society meeting. September 23, 2020 — Boston Scientific Corp. signed an investment agreement with an exclusive option to acquire Farapulse Inc., a privately-held company developing a pulsed field ablation (PFA) system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. FIH trials Ongoing (EU) FIH trial Ongoing (EU) FIH trial Ongoing (EU) FDA Trial (PULSED-AF) Ongoing. Atul Verma, MD, FHRS, Southlake Regional Health Center, Toronto, ON, Canada Point-by-point Pulsed Field Ablation (+/- Radiofrequency Ablation) To Treat Atrial Fibrillation: A First-in-human Trial . Panel and Audience Discussion—All Faculty. Ikeda et al. Coherent has locations across the globe that are available to provide support for any product, service or inquiry. Safety and acute performance of Affera's focal Pulsed Field and RF Ablation solution in a 76-patient European multicenter study involving 11 operators. Reddy et al S -AB08-02.Heart Rhythm Sessions. WASHINGTON, DC, May 8, 2020 — A new clinical trial effectively uses pulsed field (PF) energy to treat patients with persistent or paroxysmal atrial fibrillation (AF) and showcases a novel approach to performing point-by-point ablation to provide safe and effective patient Symposium attendees watched the ablation live via streaming What is Pulsed Field Ablation (IRE)? One-shot PFA catheters have been developed for pulmonary vein isolation, but they do not permit flexible lesion sets. December 19, 2019. 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