ablation catheter News
-
Galaxy Medical and Japan Lifeline Enter Distribution Agreement for Novel Pulsed Electric Field Focal Ablation Catheter
SAN CARLOS, California, April 6, 2021 — Galaxy Medical (Galaxy) and Japan Lifeline (JLL) today announced an exclusive distribution agreement for the ALPHA1 ablation catheter in the United States, developed by Japan Lifeline for use with the Galaxy CENTAURI™ Pulsed Electric Field (PEF) System. Under the terms of the agreement, Galaxy will pursue US regulatory approval for ALPHA1 in ...
-
Acutus Medical completes enrollment in IDE trial with its AcQBlate FORCE Sensing Ablation System
Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced successful completion of patient enrollment in the company’s AcQForce™ Flutter Investigational Device Exemption (IDE) clinical trial which enrolled 110 patients at 21 sites globally. The AcQForce Flutter trial was designed to ...
-
Imricor Submits for Approval to Commence VT Trial in Europe
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR), the global leader in real-time iCMR cardiac ablation products, is pleased to announce that the Company has submitted for approval to commence a real-time iCMR-guided ventricular tachycardia (VT) ablation clinical trial. The name of the study is “Vision-MR Ablation of VT” or VISABL-VT. VISABL-VT is a prospective, ...
By Imricor
-
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 ...
-
Vektor’s vMap Technology Used Alongside SAbR Planning Software (Varian, Palo Alto, CA) for Non-Invasive Mapping and Radio-ablation of Refractory Ventricular Tachycardia
Life-threatening heart rhythm disorders such as ventricular tachycardia may be eliminated using cutting-edge, non-invasive technology as an alternative to standard invasive catheter ablation procedures, in some cases. In an abstract and associated poster published at the American College of Physicians’ Southern Regional Conference, researchers report successful use of vMap™ ...
-
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 ...
-
FDA and Health Canada Approve Thermedical’s Degassed Salineto Help Reduce Risk of Stroke
MONTREAL and WALTHAM, Mass., June16, 2020–The Montreal Heart Institute(MHI) and Thermedical®, a developer of thermal-ablation systemsto treat ventricular arrhythmias, today announced the first ablation performed using the groundbreaking Durablate® retractable needle catheter and degassed saline, which together eliminateover98% of the air bubbles that can lead to stroke. Health ...
-
Adagio Medical Announces First Patient Enrollment in its iCLAS U.S. IDE Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Persistent Atrial Fibrillation
Adagio Medical, Inc. (Adagio) today announced it has enrolled the first patient in its iCLAS™ Investigational Device Exemption (IDE) trial. The FDA approved study aims to evaluate the safety and efficacy of Adagio’s ultra-low temperature intelligent Continuous Lesion Ablation System (iCLAS) in the treatment of persistent atrial fibrillation (PsAF). Data will be used to support a ...
-
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 ...
-
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 ...
-
FARAPULSE’s Pivotal ADVENT Trial underway with First Patients Treated with its Breakthrough Pulsed Field Ablation System to Treat Atrial Fibrillation
FARAPULSE Inc. today announced the first patients were treated in the ADVENT Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial Fibrillation (AF). AF is a heart rhythm disorder that affects nearly 6 million Americans and makes ...
-
Thermedical Scores Fda Breakthrough Designation For Ablation System To Treat Ventricular Tachycardia
Waltham, Mass.-based Thermedical Inc. has received a breakthrough device designation from the U.S. FDA for its saline enhanced radiofrequency (SERF) ablation system and Durablate catheter in the treatment of ventricular tachycardia (VT). The system uses a new means of biological heat to precisely deliver ablation therapy to the heart.VT is a leading cause of sudden cardiac death worldwide – ...
-
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.
-
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.
-
Procyrion Names AV Edidin, Ph.D., as Senior Vice President of Development and Manufacturing
Procyrion, Inc., a clinical-stage medical device company developing the Aortix™ system, a percutaneous blood pump initially targeted for treating patients with heart failure and worsening kidney function (cardiorenal syndrome), announced the appointment of Av Edidin, Ph.D., as Senior Vice President of Development and Manufacturing. In this role, Edidin will lead and oversee product ...
-
Adagio Medical Announces First-In-Human Use and Initiation of Multi-Center Study of Ultra-Low Temperature Cryoablation for Treatment of Recurrent Ventricular Tachycardia, Opening New Possibilities for High-Risk Patients
Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), today announced successful first-in-human use of ultra-low temperature cryoablation (ULTC) for the treatment of monomorphic VT. The two-hour mapping and ablation procedure was performed by Dr. Tom De Potter, MD, Associate Director, Cardiovascular Center ...
-
Galaxy Medical Receives $18 Million from ATP to Advance Development of Its Novel Pulsed Electric Field Ablation Therapy for Cardiac Arrhythmias
GALAXY’S PROPRIETARY CENTAURI™ SYSTEM ON TRACK FOR EU REGISTRATION AND US PIVOTAL TRIAL START LATER THIS YEAR; SHOWS BEST-IN-CLASS POTENTIAL. SAN CARLOS, California, March 16, 2021 — ATP, a leader in life science venture capital, announced today $18M in Series A financing for its portfolio company Galaxy Medical, Inc. The funds are being used to advance the development of ...
-
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 ...
-
Thermedical Announces FDA Breakthrough Device Designation
WALTHAM. Mass.. May 19,2020 - Thermedicak a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT): today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter. The FDA Breakthrough Devices Program is intended to help ...
-
Galaxy Medical ECLIPSE-AF Study to be Featured in Innovative Technology Session at EHRA 2021 Annual Scientific Meeting
SAN CARLOS, California, April 22, 2021 — Galaxy Medical announced today that the acute results of its Europe-focused ECLIPSE-AF study will be featured during the upcoming EHRA Congress in a innovative Technology presentation on April 25th by Ante Ani , M.D., Electrophysiology Laboratory Director at University Clinical Hospital in Split, Croatia, and primary investigator of the study. The ...
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you