pulmonary vein News
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Galaxy Medical Enrolls First Patients in SPACE-AF Study SAN
SAN CARLOS, California, September 20, 2021 — Galaxy Medical announced today the initiation of the SPACE-AF study with enrollment of the first two patients at Southlake Regional Health Centre in Newmarket, Canada. In the study, the CENTAURI Pulsed Electric Field (PEF) ablation system will be used to ablate both the pulmonary veins and posterior walls in patients with persistent atrial ...
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First-in-Human Trial of Pulsed Field Ablation with Kardium’s Globe® PF System
VANCOUVER, British Columbia – Kardium Inc. announces the completion of successful first-in-human (FIH) procedures with the Globe Pulsed Field System. Dr. Vivek Reddy of Mount Sinai Hospital in New York, USA and Prof. Petr Neužil of Na Homolce Hospital in Prague, Czech Republic, performed the procedures in Prague last week. Dr. Jacob Koruth of Mount Sinai Hospital joined Dr. Reddy and Prof. ...
By Kardium Inc.
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Kardium® announces successful results from the GLOBAL-AF study
VANCOUVER, British Columbia — Kardium Inc. today announced that the Globe® Mapping and Ablation System has successfully demonstrated safety and efficacy in the GLOBAL-AF study. The results of the study were published in the Journal of Cardiovascular Electrophysiology. The study demonstrated a 76% percent freedom from atrial fibrillation at 12 months after a single treatment with the ...
By Kardium Inc.
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Galaxy Medical’s ECLIPSE-AF Study 90 Day Remapping Results to be Featured at the 2021 Stanford Biodesign New Arrhythmia Technologies Retreat
SAN CARLOS, California, July 22, 2021 — Galaxy Medical announced today that the 90 day remapping results of its ECLIPSE-AF study will be featured at the 2021 Stanford Biodesign New Arrhythmia Technologies Retreat on July 27th. Ante Ani, M.D., Electrophysiology Laboratory Director at University Clinical Hospital in Split, Croatia, and primary investigator of the study will deliver the ...
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Kardium performs first cases with the Globe® Positioning System
VANCOUVER, British Columbia – Kardium is pleased to announce the first clinical use of the Globe Positioning System (GPS™) – the new 3D mapping and navigation feature of its flagship product, the Globe® Mapping and Ablation System. The Globe System is the most complete solution for the treatment of atrial fibrillation (AF) – the world’s most common heart rhythm ...
By Kardium Inc.
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Galaxy Medical Releases ECLIPSE-AF Remapping Data at Stanford Biodesign Retreat and Update on System Interoperability
SAN CARLOS, California, July 28, 2021 — Galaxy Medical announced today that the ECLIPSE-AF 90-day remapping data, presented at the Stanford BioDesign New Arrhythmia Technologies retreat, demonstrated durable lesions and chronic pulmonary vein isolation (PVI). Also, the company has recently treated patients in the same study using CE-Marked catheters and mapping systems from Boston ...
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Kardium receives CE mark for Globe® Mapping and Ablation System
VANCOUVER, British Columbia – Kardium Inc. has received CE mark approval for its Globe Mapping and Ablation System – the most complete solution for the treatment of atrial fibrillation (AF). AF is the world’s most common heart rhythm disorder, affecting more than 37 million people. This approval allows Kardium to begin commercial sales of the Globe System in Europe. “This ...
By Kardium Inc.
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Kardium® announces new financing to commercialize the Globe® System for the treatment of atrial fibrillation
VANCOUVER, B.C. – Kardium Inc., developer of the Globe® Mapping and Ablation System for the treatment of atrial fibrillation, announced today that it has raised an undisclosed amount in a new financing round. The financing was led by funds and accounts advised by T. Rowe Price Associates, Inc., and included participation from other new and existing Kardium shareholders. Kardium was ...
By Kardium Inc.
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Kardium Marks First Commercial Procedures of Globe® Mapping and Ablation System
VANCOUVER, British Columbia – Kardium Inc. announced the first commercial procedures with the Globe Mapping and Ablation System. The Globe System is the most complete solution for the treatment of atrial fibrillation (AF) – the world’s most common heart rhythm disorder, affecting more than 37 million people. The first patients were treated in Europe. During the last few weeks, ...
By Kardium Inc.
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First Patients in the U.S. Enrolled in Biosense Webster Clinical Study To Evaluate VARIPULSE™ Catheter for Atrial Fibrillation
Johnson & Johnson MedTech* announced today that Biosense Webster, Inc., a worldwide leader in the science and technology of cardiac arrhythmia treatment, enrolled the first patients in its admIRE clinical study in the United States. admIRE is a prospective, multi-center, non-randomized study that will enroll more than 400 patients in the U.S. to evaluate the safety and effectiveness of ...
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FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval
FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial ...
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Adagio Medical Receives CE Mark Approval for its iCLAS Cryoablation System and Prepares for European Commercial Launch
Adagio Medical, Inc., announces that it has received CE Mark approval for its ultra-low temperature intelligent Continuous Lesion Ablation System (iCLAS) for the endocardial treatment of paroxysmal (PAF) and persistent (PsAF) atrial fibrillation and atrial flutter. “More than half of all atrial fibrillation (AF) patients are diagnosed with PsAF. There is a strong demand to treat this ...
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Kardium announces $115M in new financing for innovative atrial fibrillation treatment
VANCOUVER, British Columbia – Kardium Inc., developer of the Globe® Mapping and Ablation System for the treatment of atrial fibrillation, has raised US $115 million in a new financing round. The round is led by Fidelity Management & Research Company LLC., together with follow-on participation by funds and accounts advised by T. Rowe Price Associates, Inc. The new financing will be ...
By Kardium Inc.
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Boston Scientific Announces Expanded Investment and Exclusive Acquisition Option Agreement with Farapulse, Inc.
Boston Scientific Corporation (NYSE: BSX) today announced it has 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. This PFA system – comprising a sheath, generator and catheters – is intended to ablate ...
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Adagio Medical Announces Successful First-In-Human Cases of Pulsed Field Cryoablation for Treatment of Atrial Fibrillation
Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), today announced first-in-human cases of pulsed field cryoablation (PFCA) for the treatment of atrial fibrillation (AF). The cases were performed at Medicover Hospital, Warsaw, Poland by Dr. Pawel Derejko, Head of the Department of Cardiology at Medicover and ...
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AtriCure’s EPi-Sense System Approved by FDA for Treatment of Long-Standing Persistent Afib Patients
Superiority trial showed a 29% difference in effectiveness at 12 months and a 35% difference in effectiveness at 18 months for long-standing persistent Afib patients. Study also showed improved Electrophysiology Lab efficiency AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced U.S. Food and ...
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Kardium’s Globe® System Begins Clinical Trial at St. Paul’s Hospital
VANCOUVER, British Columbia –?Kardium?Inc.?announces a successful first-in-BC investigational* clinical procedure using the Globe® Mapping and Ablation System. Dr. Marc Deyell of St. Paul’s Hospital leads the study using the Globe System to navigate inside the heart and diagnose where the rhythm disturbances occur. Once identified, the same device can then deliver immediate ...
By Kardium Inc.
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Acutus Medical Initiates CE Mark Study for Focal Pulsed Field Ablation Therapy to Treat Atrial Fibrillation
Acutus Medical, Inc. (Nasdaq: AFIB) (“Acutus”), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the initiation of AcQForce PFA-CE, a new clinical study that will evaluate the safety and performance of the company’s focal force sensing Pulsed Field Ablation (PFA) catheter and system in combination with ...
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First Patients Treated with Galaxy Medical’s CENTAURI Pulsed Electric Field Cardiac Ablation System
MENLO PARK, California, October 9, 2020 — Galaxy Medical, (Galaxy), a developer of Pulsed Electric Field (PEF) technology for the treatment of cardiac arrhythmias, today announced that the first patients were successfully treated with the proprietary CENTAURI™ System by Dr. Ante Ani in Split, Croatia as part of the ECLIPSE-AF study. This multicenter trial is designed to assess the ...
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Adagio Medical Announces Publication of Cryocure-2 Data Reporting 85% Freedom from AF at 12 Months After a Single Ablation Procedure in Patients with Persistent Atrial Fibrillation and Discusses Current Status of iCLAS Cryoablation System
Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced the publication of the results of its Cryocure-2 ultra-low temperature cryoablation (ULTC) study in patients with AF in the Journal of American College of Cardiology (JACC), Clinical Electrophysiology.1 The study prospectively enrolled 79 patients at ...
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