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BioCardia Submits for FDA Approval of Morph DNA Steerable Introducer Product Family

DAIC

a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, reported it has submitted a 510(k) for approval of its patented Morph DNA Steerable Introducer Sheath. mtaschetta-millane Wed, 07/31/2024 - 07:00 July 31, 2024 — BioCardia, Inc. ,

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Boston Scientific Receives FDA Approval for FARAPULSE Pulsed Field Ablation System

DAIC

A company statement reported that its PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e.,

Ablation 111
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PO-02-157 INITIAL EXPERIENCE OF POINT BY POINT PULSED FIELD ABLATION IN COMPLEX CASES OF ATRIAL TACHYCARDIA: FEASIBILITY, OUTCOME AND SAFETY OF A NOVEL TECHNOLOGY

HeartRhythm

Pulsed-field ablation (PFA) is becoming increasingly relevant in the field of electrophysiology. Besides single-shot PFA devices for pulmonary vein isolation (PVI), point-by-point PFA is also gaining importance due to many possible applications. Data on the use is sparse, especially for atrial tachycardia (AT).

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Hemolysis Biomarkers After Pulmonary Vein Isolation via a Balloon‐In‐Basket PFA Catheter

Journal of Cardiovascular Electrophysiology

Methods In this study, blood samples were collected from 16 patients before and 24h after pulmonary vein isolation (PVI) via a novel investigational PFA-based technology.

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Boston Scientific Initiates AVANT GUARD Clinical Trial to Evaluate FARAPULSE Pulsed Field Ablation System as First-Line Treatment for Persistent Atrial Fibrillation

DAIC

Patients in the study will be randomized to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using the FARAPULSE PFA System, or receive AAD treatment, and followed for three years. The randomized AVANT GUARD trial will enroll more than 500 patients diagnosed with persistent AF at up to 75 sites globally.

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Pulse Biosciences Announces First-in-Human Procedures with its Novel CellFX Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Catheter

DAIC

a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, announced the completion of the first five procedures in its first-in-human feasibility study with its novel CellFX nsPFA cardiac catheter.

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Durable pulmonary vein isolation with optimized high?power and very high?power short?duration temperature?controlled ablation: A step?by?step guide

Journal of Cardiovascular Electrophysiology

Abstract Introduction Through systematic scientific rigor, the CLOSE guided workflow was developed and has been shown to improve pulmonary vein isolation durability. However, this technique was developed at a time when using power-controlled ablation catheters with conventional power ranges was the norm.