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Afib Ablation Delivers in First Sham-Controlled Study

Med Page Today

(MedPage Today) -- LONDON -- Pulmonary vein isolation (PVI) produced real short-term improvements for people with atrial fibrillation (Afib or AF), according to the first sham-controlled trial on the subject. Continuous monitoring by implantable.

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FDA OKs Farapulse Pulsed Field Ablation System for Intermittent Afib

Med Page Today

(MedPage Today) -- The FDA approved the Farapulse pulsed field ablation (PFA) system for paroxysmal atrial fibrillation (Afib or AF), Boston Scientific announced on Wednesday. The device won an indication for the isolation of pulmonary veins in.

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Abbott Receives CE Mark for Pulsed Field Ablation System

DAIC

tim.hodson Thu, 03/27/2025 - 12:18 March 27, 2025 Abbott recently announced it has received CE Mark in Europe for the Volt PFA System to treat patients battling atrial fibrillation (AFib). Today, approximately 8 million Europeans over the age of 65 are living with AFib, a number expected to double over the next 30 years.

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Cortex Announces RESOLVE-AF Trial Evaluating Electrographic Flow (EGF) Mapping for use in Atrial Fibrillation Ablation

DAIC

The international, multi-center trial will provide clinical evaluation of Cortex's 510(k) cleared Ablamap System with electrographic flow (EGF) and newly released Ablacath Mapping Catheter basket mapping catheter to identify extra-pulmonary vein EGF sources.

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Medtronic’s PulseSelect Becomes First FDA-Approved PFA System

CardiacWire

The AFib pulsed field ablation treatment era officially began in the US last week, following the FDA approval of Medtronic’s PulseSelect Pulsed Field Ablation System for the treatment of both paroxysmal and persistent atrial fibrillation. PFA systems use electroporation (short electrical pulses) to achieve pulmonary vein isolation.

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SHAM-PVI: Pulmonary Vein Isolation vs. Sham Intervention in Patients With Symptomatic AFib

American College of Cardiology

Compared with a sham procedure, pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation (AFib) burden at six months, according to results from the SHAM-PVI trial presented at ESC Congress 2024 in London and simultaneously published in JAMA.

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Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE Platform for the Treatment of Paroxysmal Atrial Fibrillation

DAIC

The VARIPULSE Platform is designed to enable pulmonary vein isolation with the versatility of a catheter loop, a simple generator user interface, and a mapping system that provides an intuitive, reproducible workflow with real-time visualization, contact indicator, and PF tagging mechanisms. In the U.S.,