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Pulmonary Vein Articles & Analysis

21 news found

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 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

” “Almost all patients with persistent AF in the Cryocure-2 study underwent ablations which combined pulmonary vein isolation with additional lesions, mostly on the posterior wall of the left atrium,” added Lucas Boersma, MD, PhD at St. ...

ByAdagio Medical, Inc.


First Patients in the U.S. Enrolled in Biosense Webster Clinical Study To Evaluate VARIPULSE™ Catheter for Atrial Fibrillation

First Patients in the U.S. Enrolled in Biosense Webster Clinical Study To Evaluate VARIPULSE™ Catheter for Atrial Fibrillation

This ablation technique may help spare other tissue types from inadvertent injury to adjacent structures such as the esophagus, pulmonary vein connective tissue and the phrenic nerve.3 “The enrollment of the first patient in the admIRE study marks an important milestone in our journey to bring forward a best-in-class PFA platform to our customers, who have ...

ByJohnson & Johnson Medical Devices Business Services, Inc.


Kardium’s Globe® System Begins Clinical Trial at St. Paul’s Hospital

Kardium’s Globe® System Begins Clinical Trial at St. Paul’s Hospital

The Globe Catheter has 122 electrodes that allow for rapid, single-shot pulmonary vein isolation (PVI), high-definition mapping in real-time, and atrial ...

ByKardium Inc.


Adagio Medical Announces Successful First-In-Human Cases of Pulsed Field Cryoablation for Treatment of Atrial Fibrillation

Adagio Medical Announces Successful First-In-Human Cases of Pulsed Field Cryoablation for Treatment of Atrial Fibrillation

The patients, a 32-year-old man with paroxysmal AF and a 60-year-old man with persistent AF underwent successful pulmonary vein and posterior wall isolation using a dedicated PFCA catheter powered by the proprietary Adagio iCLAS™ cryoablation and pulsed field ablation (PFA) consoles. ...

ByAdagio Medical, Inc.


First U.S. patients with persistent cardiac arrythmias treated using Volta Medical’s artificial intelligence-based analysis

First U.S. patients with persistent cardiac arrythmias treated using Volta Medical’s artificial intelligence-based analysis

About the TAILORED-AF trial TAILORED-AF is an international, multicenter trial designed to determine if a tailored VX1 AI software-guided ablation strategy targeting areas of spatiotemporal dispersion in combination with pulmonary vein isolation (PVI) is superior to a conventional anatomical ablation strategy targeting PVI alone for the treatment of persistent ...

ByVolta Medical


First-in-Human Trial of Pulsed Field Ablation with Kardium’s Globe® PF System

First-in-Human Trial of Pulsed Field Ablation with Kardium’s Globe® PF System

PFA delivered by the Globe PF System is unique in that it achieves true single-shot isolation; a single application of the GlobePulse™ Waveform achieves pulmonary vein isolation (PVI) in as little as 3 seconds. The Globe PF System also provides high-definition mapping: GPS™ 3D Maps show the position of the Globe Catheter in the heart; CONTACT™ ...

ByKardium Inc.


Acutus Medical Initiates CE Mark Study for Focal Pulsed Field Ablation Therapy to Treat Atrial Fibrillation

Acutus Medical Initiates CE Mark Study for Focal Pulsed Field Ablation Therapy to Treat Atrial Fibrillation

As physicians, we know that the majority of our patients that come back for re-treatment following ablation for atrial fibrillation have triggers in various locations beyond the standard course of care, and it’s imperative for us to research beyond pulmonary vein isolation-only utilizations,” said Dr. Steven Mickelsen, Acutus’ Chief ...

ByAcutus Medical, Inc.


Galaxy Medical Enrolls First Patients in SPACE-AF Study SAN

Galaxy Medical Enrolls First Patients in SPACE-AF Study SAN

In the study, the CENTAURI Pulsed Electric Field (PEF) ablation system will be used to ablate both the pulmonary veins and posterior walls in patients with persistent atrial fibrillation (AF). ...

ByGalvanize Therapeutics, Inc.


Galaxy Medical Releases ECLIPSE-AF Remapping Data at Stanford Biodesign Retreat and Update on System Interoperability

Galaxy Medical Releases ECLIPSE-AF Remapping Data at Stanford Biodesign Retreat and Update on System Interoperability

SAN CARLOS, California, July 28, 2021 — Galaxy Medical announced today that the ECLIPSE-AF 90-day remapping data, presented at the Stanford BioDesign New Arrhythmia Technologies retreat, demonstrated durable lesions and chronic pulmonary vein isolation (PVI). Also, the company has recently treated patients in the same study using CE-Marked catheters and ...

ByGalvanize Therapeutics, Inc.


Galaxy Medical’s ECLIPSE-AF Study 90 Day Remapping Results to be Featured at the 2021 Stanford Biodesign New Arrhythmia Technologies Retreat

Galaxy Medical’s ECLIPSE-AF Study 90 Day Remapping Results to be Featured at the 2021 Stanford Biodesign New Arrhythmia Technologies Retreat

The proprietary CENTAURI Connect module which allows physicians to perform PEF ablation procedures with focal catheters and marketed mapping systems, saving training time, workflow adjustments, and cost. “Remapping the pulmonary veins is the gold standard method of determining the efficacy of emerging ablation technologies and building on the previously ...

ByGalvanize Therapeutics, Inc.


The Ultimate List of Attractive MedTech M&A Targets

The Ultimate List of Attractive MedTech M&A Targets

That study showed that all endpoints of the pivotal study were achieved, demonstrating significantly faster pulmonary vein isolation (PVI) ablation and procedures times with the HeartLight X3 System compared to the previous generation system, the HeartLight endoscopic ablation system, and with comparable safety and efficacy. ...

ByAnuncia Medical, Inc.


AtriCure’s EPi-Sense System Approved by FDA for Treatment of Long-Standing Persistent Afib Patients

AtriCure’s EPi-Sense System Approved by FDA for Treatment of Long-Standing Persistent Afib Patients

“The improvement using the EPi-Sense System for posterior left atrial wall and pulmonary vein ablation, in combination with an endocardial catheter to address lesion gaps, is truly remarkable. ...

ByAtriCure, Inc.


Kardium announces $115M in new financing for innovative atrial fibrillation treatment

Kardium announces $115M in new financing for innovative atrial fibrillation treatment

The Globe Mapping and Ablation System consists of a sophisticated catheter with a 122-electrode array and advanced software that enable rapid pulmonary vein isolation, high-definition mapping, and the ability to ablate anywhere in the atrium – all with a single catheter. ...

ByKardium Inc.


FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval

FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval

Of note, more than 130 patients underwent prospective reassessment (remapping) 3 months after their procedures to confirm the durability of FARAPULSE PFA therapy to isolate the pulmonary veins. Top line safety results from the Company’s clinical studies showed that the severe complications of PV stenosis and both esophageal and phrenic nerve injury were ...

ByBoston Scientific


Kardium performs first cases with the Globe® Positioning System

Kardium performs first cases with the Globe® Positioning System

It is a powerful 122-electrode mapping and ablation system that combines best-in-class technologies into a single catheter, uniting the rapid pulmonary vein isolation (PVI) of balloon catheters, the flexibility of single-tip catheters, and the high-definition mapping of multi-electrode mapping catheters. ...

ByKardium Inc.


First Patients Treated with Galaxy Medical’s CENTAURI Pulsed Electric Field Cardiac Ablation System

First Patients Treated with Galaxy Medical’s CENTAURI Pulsed Electric Field Cardiac Ablation System

” As part of the ECLIPSE-AF study, patients will be assessed and followed with standard safety and efficacy procedures including acute demonstration of entrance and exit block, three-month electrophysiologic remapping to confirm pulmonary vein isolation, cerebral MRI and upper GI endoscopy. PEF technology utilizes high voltage, high frequency bursts of ...

ByGalvanize Therapeutics, Inc.


Boston Scientific Announces Expanded Investment and Exclusive Acquisition Option Agreement with Farapulse, Inc.

Boston Scientific Announces Expanded Investment and Exclusive Acquisition Option Agreement with Farapulse, Inc.

“The tissue-selective Farapulse PFA technology is a promising energy source for cardiac ablation – including pulmonary vein isolation – with recent study results demonstrating the effectiveness of the ultra-rapid approach,” said Allan Zingeler, president and chief executive officer, Farapulse, Inc. ...

ByBoston Scientific


Kardium® announces successful results from the GLOBAL-AF study

Kardium® announces successful results from the GLOBAL-AF study

“The Globe System has demonstrated the ability to provide rapid and effective pulmonary vein isolation. In addition, the ability to perform high resolution mapping and ablation of the atrium will deliver a unique and comprehensive treatment for patients that has the potential to further improve outcomes and advance new strategies for the treatment of ...

ByKardium Inc.


Adagio Medical Receives CE Mark Approval for its iCLAS Cryoablation System and Prepares for European Commercial Launch

Adagio Medical Receives CE Mark Approval for its iCLAS Cryoablation System and Prepares for European Commercial Launch

“The multicenter European CryoCure II clinical study has shown that we can perform pulmonary vein isolation (PVI) in combination with other ablations in both atria (e.g. posterior wall box and cavo tricuspid isthmus isolation), even in the most difficult to treat PsAF patients. ...

ByAdagio Medical, Inc.


Kardium® announces new financing to commercialize the Globe® System for the treatment of atrial fibrillation

Kardium® announces new financing to commercialize the Globe® System for the treatment of atrial fibrillation

The Globe System is a powerful mapping and ablation solution that consists of a sophisticated catheter with 122 electrodes and advanced software, that together enable rapid pulmonary vein isolation, high resolution mapping, and the ability to ablate anywhere in the atrium. ...

ByKardium Inc.

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