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. The trials were funded by Affera Inc, the manufacturer of this RF/PF system. NOTE: The Affera catheter can actually do both PFA and RFA (Radio Frequency Ablation). Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure. Affera, Inc. pays an average salary of $3,614,601 and salaries range from a low of $3,140,022 to a high of $4,151,870. "These findings translated to exceptional safety and acute performance in a clinical setting. Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it has entered into a definitive agreement to acquire Affera, Inc., a Boston area-based, privately held medical technology company. Affera has announced that the first patient was treated in the recently approved SPHERE PerAF trial, a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal randomised trial, to evaluate the safety and effectiveness of the Affera system and Sphere-9 catheter for the treatment of persistent atrial fibrillation (AF). Affera, Inc. | 6,092 followers on LinkedIn. Country United States (3) State Massachusetts (3) City Bedford (1) Newton (2) Clear Filters 3 Jobs| Sort By Mapping Specialist Newton , Massachusetts , United States Full-time | Fully remote Medical Device Assembler Symptomatic paroxysmal atrial fibrillation (PAF) documented by: Severe mitral regurgitation (regurgitant volume 60 mL/beat, regurgitant fraction 50%, and/or effective regurgitant orifice area 0.40cm2. This platform has the potential to transform the way AF therapy is delivered.". Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing demands for cardiac arrhythmia treatment. January 11, 2022 Medtronic plc on Monday announced that it has inked a deal to acquire Boston-based cardiac technology firm Affera Inc. Affera develops technology aimed at treating irregular. The Affera system is not currently approved for commercial use. What are clinical trials? Individual salaries will, of course, vary depending on the job, department, location, as well as the individual skills and education of each employee. Doron is the founder and CEO of Affera, Inc. Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor. Experimental: SpherePVI Catheter. The trial is comparing a conventional radiofrequency ablation catheter to the Sphere-9catheter which is capable of delivering energy with a larger ablative footprint to facilitate lesion overlap and procedural efficiency. Chronic efficacy will be evaluated as freedom from documented arrhythmia recurrence outside of a 90-day blanking period. Summary: A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI Multi-Ablation System for treating paroxysmal atrial fibrillation. 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. 7 About Biosense Webster, Inc. "First Preclinical And Clinical Demonstration Of Transient Myocardial Stunning / Reversible Electroporation With Pulsed Field Energy: A Novel Electrophysiological Maneuver" by, "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, "A Lattice Tip Pulsed Field Ablation For Pulmonary Vein Isolation: Biophysical Characterization, Lesion Durability And Safety Evaluation" by, "Durability And Safety Of Vein Isolation And Linear Atrial Lesions With Pulsed Field Ablation Using A 9mm Lattice-tip Catheter: A Preclinical Assessment" by, "Preclinical Assessment Of Feasibility And Durability Of Mitral Isthmus Ablation Using Pulsed Field Ablation" by, "The Effect Of Pulsed Field Ablation On The Esophagus: A Preclinical Model Using A Novel Lattice Tip Catheter" by. The trials were funded by Affera Inc, the manufacturer of this RF/PF system. I started with persistent AFIB March 5th, and was in AFIB 24 X 7. 6 Estimates state that by 2030 the number of people with AF is projected to increase by up to 70 percent. Please remove one or more studies before adding more. Acute illness, active systemic infection, or sepsis. Jordan ValleyAffera, Inc.857-304-4030[emailprotected] www.affera.com, Cision Distribution 888-776-0942 The following are also considered primary effectiveness endpoint failures: Choosing to participate in a study is an important personal decision. Please remove one or more studies before adding more. Affera, Inc. is a venture-backed medical device company dedicated to developing unrivaled solutions for the treatment of cardiac arrhythmia, a prevalent condition affecting millions of patients. That said, those selected for PFA, like me, may get both - I received RFA on the pulmonary veins and PFA on the posterior wall. First enrollment comes as investors provide $75M toward an oversubscribed Series C financing. Any condition contraindicating chronic anticoagulation. Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing cardiac arrhythmia market. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure. Contraindication to both computed tomography and magnetic resonance angiography. 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 outcomes. About this study. The first patient was treated at New York's Mount Sinai Hospital by Dr. Vivek Reddy, the Helmsley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai. Failure or intolerance of at least one Class I or III anti-arrhythmic drug (AAD). Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements. Sphere-9 Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System, Minimally invasive catheter mapping and ablation procedure, THERMOCOOL SMARTTOUCH SF Catheter; SMARTABLATE System; CARTO 3 System, Total energy application time during the index ablation procedure, Time from start to end of energy delivery. from 8 AM - 9 PM ET. Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure. Medical device company Medtronic plc. The Affera system is not currently approved for commercial use. enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results. There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data. It was encouraging that, just as in the initial European trials, this first procedure was performed efficiently and successfully.". Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure. You can email the site owner to let them know you were blocked. For more. 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. I was part of the Affera Clinical Trial, and my doctor did the cardioablation using PFA for the posterior wall. History of blood clotting or bleeding abnormalities. Affera is a clinical-stage medical technology company developing innovative devices for the treatment of atrial fibrillation, a common cardiac arrhythmia affecting millions of patients. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Affera Announces First Patient Treated in SPHERE Per-AF IDE Trial NEWTON, Mass., Dec. 20, 2021 /PRNewswire/ -- Affera Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today that the first patient was treated in the recently approved SPHERE PerAF Trial, a U.S. Food and Drug Administration. Moderate to severe mitral valve stenosis. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Designed to optimize procedural efficiency and efficacy across a broad range of cardiac arrhythmias, the system has been used to treat 170 patients. Medtronic plc MDT recently made a major investment to advance in the prospering field of electrophysiology (EP). Jobs at Affera View 3 Openings View our current openings below, or e-mail talent@affera.com for more information. Affera was founded to address an unmet need in cardiac arrhythmia treatment. Dec. 20, 2021, 08:00 AM. Support clinical trial activities including coordination with trial managers and study sites, system setup and testing, and mapping and . For more information, please visit www.affera.com. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or . MEDIA CONTACT Katie Arnold SPRIG Consulting LLC +1 (408) 805-0520 Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure. Medtronic completes acquisition of Affera prnewswire.com 14 Like . Apply Now Field Clinical Specialist. 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. Affera is developing a comprehensive integrated platform to efficiently deliver durable therapy for a broad set of cardiac arrhythmia patients. The Affera system and Sphere-9 catheter are not currently approved for commercial use. Inclusion Criteria: Symptomatic paroxysmal atrial fibrillation (PAF) documented by: A physician's note indicating recurrent, self-terminating AF. Patients affected by this arrhythmia have an increased risk of stroke and heart failure, with a significant reduction in functional capacity and quality of life. Who are Affera, Inc. 's competitors? 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, "Point-by-Point Pulsed Field Ablation (+/- Radiofrequency Ablation) to Treat Atrial Fibrillation: A First-in-Human Trial" by, "A Lattice-Tip Focal Ablation Catheter that Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial,", "Pulsed-Field Ablation Using a Lattice Electrode for Focal Energy Delivery: Biophysical Characterization, Lesion Durability and Safety Evaluation,", "Focal Pulsed Field Ablation for Pulmonary Vein Isolation and Linear Atrial Lesions: A Preclinical Assessment of Safety and Durability,", "Pulmonary Vein Isolation With Combination Of Radiofrequency And Pulse Field Energy Using A Novel Lattice Tip Electrode: A First In Human Trial" by, "Safety Of A Combined Radiofrequency + Pulsed Field Ablation Approach To Pulmonary Vein Isolation In A First-in-human Clinical Trial" by, "Catheter Ablation Of Scar-related Ventricular Tachycardia With A Novel Lattice Electrode Rf Ablation Catheter: A First In Human Clinical Trial" by. Affera is a venture-backed medical device company founded by a seasoned team of leaders in the industry. See also Status Clinical Trial Phase; Recruiting NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) : Phase 2: Recruiting NCT04115735 - His Bundle Recording From Subclavian Vein : Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study : N/A . When carefully conducted, they are the safest and. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH SF radiofrequency ablation catheter (control device). Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, Late-Breaking Clinical Trials - Innovation Boulevard. You have reached the maximum number of saved studies (100). Both were done using the Affera Sphere 9 mapping system, which can perform switch between either technology. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation. Time Frame: 6 months (Clinical Trial), A Safety and Performance Assessment of the Affera SpherePVI Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation, 18 Years to 75 Years (Adult, Older Adult), Institute Klinicke a Experimentalni Mediciny. Documented left atrial thrombus on imaging. Talk with your doctor and family members or friends about deciding to join a study. Alternatives and possible competitors to Affera, Inc. may include Arcellx, Acceleron Pharma, and Asklepios BioPharmaceutical. We welcome our new investors and believe the round further validates the significant potential of our platform to address critical unmet needs within electrophysiology," commented Doron Harlev, CEO and founder of Affera. Subjects treated with the SpherePVI Catheter; Clinical Trial Outcome Measures Primary Measures. Vulnerable subject (such as a prisoner or handicapped or mentally disabled person). Additionally, the company announced it closed an oversubscribed $75M Series C financing. They still used RF for the pulmonary veins. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention. Failure or intolerance of at least one Class I-IV anti-arrhythmic drug. Dr. Reddy commented "SPHERE Per-AF introduces focal pulsed field ablation and is the first randomized catheter ablation IDE trial to treat persistent atrial fibrillation. With a dynamic team of strong engineers and business professionals, and world-renowned clinical partners, the company has attracted talent across the country as it continues to grow. Severe mitral regurgitation (regurgitant volume 60 mL/beat, regurgitant fraction 50%, and/or effective regurgitant orifice area 0.40cm2). Symptomatic PerAF documented by (1) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND either (2a) a 24-hour Holter documenting continuous AF within the past year OR (2b) two electrocardiograms (from any form of rhythm monitoring, including consumer devices) taken at least 7 days apart within the past year, each showing continuous AF. We are developing an innovative system to treat . ( NYSE:MDT) recently revealed that it has entered into a definitive agreement to acquire Affera, a medical technology company. About Affera Affera, Inc. is a venture-backed medical device company dedicated to developing unrivaled solutions for the treatment of cardiac arrhythmia, a prevalent condition affecting millions of patients worldwide. Designed to optimise procedural efficiency and efficacy across a broad range of cardiac arrhythmias, the Affera system has been used to treat over 275 patients. Affera, Inc. employs 8 employees. The Affera system is not currently approved for commercial use. Affera, Inc. Newton, MA Just now Be among the first 25 applicants See who Affera, Inc. has hired for this role . 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. Clinical Program Management will manage the operational aspects of clinical trials for Affera''s Class II and III medical . We are pleased to join this round and look forward to advancing this much needed treatment option for the estimated 37 million people worldwide that live with this condition. Willing and able to provide informed consent. Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve). For general information, Learn About Clinical Studies. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Affera is developing a comprehensive integrated platform to efficiently deliver durable therapy for a broad set of cardiac arrhythmia patients. "With its robust platform, clinical evidence, and product pipeline, Affera stands out in the rapidly growing electrophysiology segment," stated Jeffrey Schwartz, Managing Director at Bain Capital Life Sciences. Uncontrolled heart failure or NYHA Class III or IV heart failure. Suitable candidate for catheter ablation. Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page. PV remapping, performed in 110 patients at 93.0 30.1 days, demonstrated durable PVI in 84.8% of PVs (64.5% of patients), and 96.0% of PVs (84.1% of patients) treated with the optimized biphasic energy PFA waveform. The purpose of this study is to evaluate the safety and effectiveness of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System for the treatment of symptomatic persistent atrial fibrillation (PerAF) refractory or intolerant to drugs using radiofrequency (RF) and pulsed field (PF) ablation. Study Design Study Type: Interventional Anticipated Enrollment : 50 participants Allocation: N/A Intervention Model: Single Group Assignment Masking: Click to reveal Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. Acquired by Boston Scientific in 2012, Rhythmia became Boston Scientific's cardiac mapping and navigation division, where Doron served as Vice President of Product and Technology. Why Should I Register and Submit Results? Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results. "The company is building best in class clinical options for electrophysiologists and patients, positioning it to become a significant platform for the treatment of Afib. Acute illness, active systemic infection, or sepsis. We are developing a comprehensive, integrated platform that includes RF/PF ablation and mapping catheters, a mapping system, and an ablation system. ClinicalTrials.gov Identifier: NCT05120193, Interventional Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, occurring in 1-2% of the general population. 62.171.159.34 Percentage of subjects experiencing a primary safety event. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Affera, Inc. has raised $5M. Cloudflare Ray ID: 767ecb108f62914c "Esophageal Effects Of Focal Pulsed Field Ablation Using A Novel Expandable Spherical Catheter" by Iwanari Kawamura, et. Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation solution, for the treatment of patients with cardiac arrhythmias (irregular heartbeats) such as atrial fibrillation (AF). We look forward to another exciting year as we continue to expand our efforts with the Sphere-9 catheter and beyond. You have reached the maximum number of saved studies (100). Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. "Temperature-controlled Lattice-tip Ablation Catheter Improves Clinical Outcomes In Patients With Paroxysmal Atrial Fibrillation" by Mohit K. Turagam, et. . Affera designs and manufactures cardiac mapping and navigation systems and catheter-based . Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. Prior to Affera, Doron co-founded and served as co-CEO at Rhythmia Medical, which developed a unique Electroanatomical Mapping System for the treatment of Cardiac Arrhythmia. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Why Should I Register and Submit Results? Current or anticipated participation in any other clinical trial of a drug, device, or biologic during the duration of the study, unless pre-approved by the Sponsor. For more about Pulsed Field Ablation, see my 2020 AF Symposium summaries of . The action you just performed triggered the security solution. For general information, Learn About Clinical Studies. Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure. "Is There Any Significant Thermal Effect During Focal Biphasic Pulse Field Ablation Of Atrial Tissue? The acquisition expands the company's cardiac ablation portfolio to include its first-ever cardiac mapping and navigation platform that encompasses a differentiated, fully-integrated diagnostic, focal pulsed field and radiofrequency ablation solution. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure). Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure. ClinicalTrials.gov Identifier: NCT05115214, Interventional This was a first-in-human, prospective, multicenter, single-arm, clinical study of the lattice-tip catheter RF/PF ablation system conducted at 3 centers in 2 countries (2 centers in the Czech Republic and 1 in Lithuania). Get Contact Info for All Departments. 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. Clinical trials are research studies in which people volunteer to help find answers to specific health questions. Affera, Inc. closed its last funding round on Jan 1, 2021 from a Venture - Series Unknown round. DUBLIN, Jan. 10, 2022 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it has entered into a definitive agreement to acquire Affera, Inc., a Boston area-based, privately held medical technology company. WATERTOWN, Mass., May 12, 2020 /PRNewswire/ -- Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment s. The Affera system and Sphere-9 catheter are not. al. 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. The company entered into a definitive agreement to acquire Boston-based, privately . . Suitable candidate for catheter ablation. Actual Study Start Date : Jul 22, 2021 . History of blood clotting or bleeding abnormalities. Though the AFFERA, Inc. system is very innovative and seemingly easy to use, the question is will RF really be needed or useful once Pulsed Field ablation becomes standard. NEWTON, Mass., Dec. 20, 2021 /PRNewswire/ -- Affera Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today that the first patient was treated in the recently approved SPHERE PerAF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal randomized trial, to evaluate the safety and effectiveness of the Affera system and Sphere-9 catheter for the treatment of Persistent Atrial Fibrillation (Afib). Willing and able to comply with all baseline and follow-up evaluations for the full length of the study. Affera SpherePVI Multi-Ablation System; Arms, Groups and Cohorts. Left ventricular ejection fraction (EF) < 40%. Atrial Fibrillation Affera's product portfolio is not currently . Designed to optimize procedural efficiency and efficacy across a broad range of cardiac arrhythmias, the Affera platform has been used to treat over 300 patients. Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it has entered into a definitive agreement to acquire Affera, Inc., a Boston area-based, privately held . Brief Summary: This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause. When was the last funding round for Affera, Inc.? Results: In 121 patients, acute PVI was achieved in 100% of PVs with PFA alone. Overall Status: Recruiting Start Date: 2021-10-19 Completion Date: 2023-10-19 The deal is expected to conclude in the first half of Medtronic's fiscal year 2023. Credit: Tony Webster / Flickr. A Safety and Performance Assessment of the SpherePVI Catheter and the Affera Mapping and Ablation System to Treat Paroxysmal Atrial Fibrillation.
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