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Abbott
NEWS

Abbott Secures European CE Mark for TactiFlex Duo Ablation Catheter to Treat Atrial Fibrillation

Shots: Abbott has reported CE Mark approval of TactiFlex Duo Ablation Catheter, Sensor Enabled to treat pts with atrial fibrillation (AF) Approval was based on the global FOCALFLEX CE Mark study assessing TactiFlex Duo, which showed clinically meaningful efficacy & favorable safety in the AF pts Also being evaluated in the FLEXPULSE IDE trial in the…
January 21, 2026

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NEWS

Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

Shots: Vektor Medical has received the European CE Mark approval for vMap System for non-invasive arrhythmia mapping vMap System converts 12-lead ECG data into 3D arrhythmia source maps within a minute to help identify arrhythmia drivers & guide treatment for atrial fibrillation & ventricular tachycardia The system also integrates with lab workflows to deliver rapid, non-invasive,…
October 8, 2025

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Coremap
NEWS

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

Shots: CoreMap received the US FDA’s IDE approval of CoreMap EP (Endocardial Electrophysiology) to extend the 3-phase INvENI clinical study into the US in pts with Atrial Fibrillation (AF) and long-standing persistent AF The P-I study assessed acute safety of CoreMap EP in 14 pts while P-II study showed acute safety & effectiveness in 15 pts. The…
May 30, 2025

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J&J
NEWS

Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias

Shots: The CE mark of Thermocool Smarttouch SF Catheter for cardiac arrhythmias was based on SmartfIRE trial in European patients with refractory PAF that depicted 100% acute success rate & first-pass isolation achievement in 96.8% of veins (published in Apr 2024). The Trupulse Generator hardware compatibility is anticipated in H1’25 The company has concluded…
January 13, 2025

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VIEWPOINTS_Dr. Christopher Piorkowski_2023
VIEWPOINTS

Dr. Christopher Piorkowski Shares His Views on the US FDA Approval of TactiFlex Ablation Catheter to Treat Abnormal Heart Rhythm

Shots: Christopher started by highlighting the working of the TactiFlex Ablation Catheter and how it can be used for the treatment of patients with Atrial Fibrillation He also talked about the study design and the key findings from the TactiFlex AF IDE trial. He later gave a comparative view of the TactiFlex catheter vs. conventional…
September 11, 2023

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