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Medtronic creates history with FDA approval of its novel PulseSelect™ Pulsed Field Ablation System to treat atrial fibrillation

Safe, efficient, and effective treatment for both paroxysmal and persistent atrial fibrillation
DUBLIN, Dec. 13, 2023 /PRNewswire/ Medtronic plc , a global leader in healthcare technology, today. ....

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Medtronic creates history with FDA approval of its novel PulseSelect™ Pulsed Field Ablation System to treat atrial fibrillation

/PRNewswire/ Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA). ....

United States , Rebecca Seidel , Amin Al Ahmad , Prnewswire Medtronic , Coll Cardiol , Ryan Weispfenning , Khaldoun Tarakji , Our Mission , Drug Administration , Ablation Solutions , David Medical Center , European Association Of Cardio , Exchange Commission , United States Food , Pulseselect Pulsed Field Ablation , Cardiac Ablation Solutions , Medical Center , Flexcath Contour , Chief Medical Officer , Atrial Fibrillation , Pulsed Field , Cardiovascular Diseases , Risk Factors , Update From , European Association , Cardio Thoracic Surgery ,

Doylestown Health Testing New Tech To Treat Irregular Heartbeat

UpdatedFri, Apr 9, 2021 at 3:26 pm ET
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Atrial fibrillation (also called AFib or AF) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. (Shutterstock)
DOYLESTOWN, PA Electrophysiologists at Doylestown Health are among the first in the country to test a breakthrough technology currently being studied to treat arrhythmia.
Ireland-based medical tech company Medtronic developed the new technology called the PulseSelect Pulsed Field Ablation (PFA) System, which uses pulsed electric fields to treat atrial fibrillation, also known as irregular heartbeat.
Robert Sangrigoli, MD, and John Harding, MD, used it to treat three patients last month. Dr. Harding calls the technology revolutionary: This is the next big step in cardiac ablation. ....

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Charlton among first to perform new procedure

The Herald News
FALL RIVER – Southcoast Health is enrolling patients in a new clinical trial to evaluate the use of a new heart ablation technology designed to treat atrial fibrillation.
The community health system’s Cardiovascular Care Center at Charlton Memorial Hospital was the first in the world to perform the procedure during the pivotal phase of the research trial that precedes FDA approval, said Southcoast Clinical Research Coordinator Debra Benevides.
The investigational device exemption pivotal trial is called Pulsed AF and utilizes the Medtronic PulseSelect Pulsed Field Ablation System, a breakthrough technology that uses pulsed electric fields to treat atrial fibrillation by interrupting irregular heart rhythms. ....

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Medtronic : First Procedures Performed in Trial of Technology for Atrial Fibrillation

By Michael Dabaie
Medtronic PLC said the first procedures were performed in the investigational device exemption pivotal trial of the PulseSelect Pulsed Field Ablation System.
PulseSelect uses pulsed electric fields to treat atrial fibrillation.
The first procedure in the PULSED AF pivotal trial was performed this week at Southcoast Health in Fall River, Mass., with the second procedure also at Southcoast Health. The PULSED AF Trial aims to establish the safety and efficacy of the PulseSelect System.
Atrial fibrillation is one of the most common and undertreated heart rhythm disorders, affecting more than 37 million people worldwide. The disease involves an irregular quivering or rapid heart rhythm in the upper chambers of the heart. ....

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