Left atrial diameter >50 mm (anteroposterior). 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. 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. Affera's product portfolio is not currently . 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. The Affera system and Sphere-9 catheter are not. 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. For more information, visit www.affera.com. MEDIA CONTACT: Jordan Valley Affera, Inc. 857-304-4030 media@affera.com www.affera.com SOURCE Affera, Inc. Afferas Ken Dropiewski Ken has been in the cardiac, vascular, and interventional space for over 20 years. The primary safety outcome is the incidence of the following serious device-related Primary Adverse Events (AEs) occurring within 7 days of the index ablation procedure: Acute product performance will be evaluated during the procedure and includes the following: SpherePVI Catheter handling sufficient to reach reasonable intended targets, as determined by the physician: Chronic efficacy may also be evaluated during an optional remapping procedure and will include the following: Choosing to participate in a study is an important personal decision. Time Frame: 6 months Affera designs and manufactures cardiac mapping and navigation systems and catheter-based . Severe mitral regurgitation (regurgitant volume 60 mL/beat, regurgitant fraction 50%, and/or effective regurgitant orifice area 0.40cm2). When typing in this field, a list of search results will appear and be automatically updated as you type. 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. Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function). Any condition contraindicating chronic anticoagulation. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. The Affera system is not currently approved for commercial use. 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. Aug 30, 2022. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause. Left atrial diameter >55 mm (anterioposterior). 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. Additionally, the company announced it closed an oversubscribed $75M Series C financing. Affera is developing a comprehensive integrated platform to efficiently deliver durable therapy for a broad set of cardiac arrhythmia patients. 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. Condition. Moderate to severe mitral valve stenosis. Clinical trials are research studies in which people volunteer to help find answers to specific health questions. Failure or intolerance of at least one Class I-IV anti-arrhythmic drug. The trials were funded by Affera Inc, the manufacturer of this RF/PF system. Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure. For general information, Learn About Clinical Studies. Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing demands for cardiac arrhythmia treatment. The Affera system and Sphere-9 catheter are not currently approved for commercial use. Experimental: SpherePVI Catheter. Affera is a venture-backed medical device company founded by a seasoned team of leaders in the industry. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. ( NYSE:MDT) recently revealed that it has entered into a definitive agreement to acquire Affera, a medical technology company. 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 . Designed to optimize procedural efficiency and efficacy across a broad range of cardiac arrhythmias, the system has been used to treat 170 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. 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 study results. You have reached the maximum number of saved studies (100). Performance & security by Cloudflare. When was the last funding round for Affera, Inc.? The company also announced that it closed a $75M Series C financing that will support the trial and continued development of Affera's platform. Clinical Trial Page; . Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation. Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements. Failure will be reported as both (i) recurrence of AF and (ii) recurrence of any atrial tachyarrhythmia (AF, atrial tachycardia, or atrial flutter). Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure). Clinical Trial Policy (CTP) A National Coverage Determination (NCD) that allows payment of routine items/services, and payment of the investigational item/service if it is normally covered outside of the trial and meets medical necessity requirements, in clinical trials that qualify for coverage. We are developing a comprehensive, integrated platform that includes RF/PF ablation and mapping catheters, a mapping system, and an ablation system. 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). Information provided by (Responsible Party): 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. Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it has completed the acquisition of Affera, Inc. Pretty amazing. In December 2021, Affera announced the commencement of 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 for the treatment of persistent AF. enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results. 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. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Please remove one or more studies before adding more. This 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. Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure). Information provided by (Responsible Party): This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Contraindication to both computed tomography and magnetic resonance angiography. WATERTOWN, Mass., May 12, 2020 /PRNewswire/ -- Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment s. For more. 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. al. The Affera system includes the Sphere-9 catheter and integrated Prism-1 mapping system to enable the rapid creation of detailed maps, as well as the versatile HexaGEN ablation system to deliver either Pulsed Field or Radiofrequency lesion sets in a variety of substrates. History of blood clotting or bleeding abnormalities. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause. 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. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Percentage of subjects experiencing a primary safety event [TimeFrame:6 months], Major vascular access complications / bleeding, Hospitalization (initial and prolonged) due to cardiovascular or pulmonary AE, Cardiac tamponade / perforation (up to 30 days), Atrio-esophageal fistula (up to 180 days), Percentage of subjects with acute procedure success [TimeFrame:Index ablation procedure], Percentage of subjects experiencing a device- or procedure-related serious adverse event [TimeFrame:12 months], Product performance evaluated on a 5-point semi-quantitative scale ("strongly disagree" to "strongly agree") [TimeFrame:Index ablation procedure], catheter delivery to the desired ablation sites, safe removal of catheter from the subject, Electroanatomical navigation and/or mapping sufficient to aid the procedure (if used), Generation of acceptable acute ablation lesions, Percentage of subjects free from documented recurrence outside of the blanking period [TimeFrame:12 Months], Percentage of pulmonary veins remaining isolated at remapping [TimeFrame:75 days], The number of pulmonary veins that remain isolated, The number of patients with all pulmonary veins isolated, A physician's note indicating recurrent, self-terminating AF, At least two electrocardiographically documented AF episodes within 12 months prior to enrollment.
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