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Catheter Single Articles & Analysis

18 news found

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 System is an all-in-one solution for treating atrial fibrillation, affecting more than 59 million people worldwide and approximately 200,000 in Canada1,2. The Globe System is a single catheter solution for high-definition mapping and ablation. The Globe Catheter has 122 electrodes that allow for rapid, single-shot ...

ByKardium Inc.


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. ...

ByKardium Inc.


Galaxy Medical Enrolls First Patients in SPACE-AF Study SAN

Galaxy Medical Enrolls First Patients in SPACE-AF Study SAN

Recently, Galaxy has also enrolled additional subjects in the ECLIPSE-AF study using the CARTO mapping system and CE-Marked catheters manufactured by Biosense Webster, achieving CENTAURI compatibility with the three market leading cardiac mapping systems and their associated catheters. ...

ByGalvanize Therapeutics, Inc.


Adagio Medical Reports 85% Freedom from AF at 12 Months After a Single Ablation Procedure in Patients with Persistent Atrial Fibrillation and Presents Recent Developments of Pulsed Field Cryoablation Technology

Adagio Medical Reports 85% Freedom from AF at 12 Months After a Single Ablation Procedure in Patients with Persistent Atrial Fibrillation and Presents Recent Developments of Pulsed Field Cryoablation Technology

At 12 months, freedom from AF after a single procedure was 82%, with 1.5% procedural complications rate when using newer generations of ULTC technology. ...

ByAdagio Medical, Inc.


Nipro Medical Corporation announces the creation of Vascular Division in the U.S.

Nipro Medical Corporation announces the creation of Vascular Division in the U.S.

The following products will join the Vascular portfolio: Makoto Intravascular Imaging System, the only FDA-cleared dual-modality catheter and imaging system indicated for the detection of lipid core plaque (LCP) and the identification of plaque and patients at higher risk of MACE, from Infraredx, a Nipro company. Dualpro IVUS+NIRS Imaging Catheter, a ...

ByInfraredx, 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.


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 ...

ByKardium Inc.


Minimally Invasive Ellipsys System Creates Fused, Permanent Vascular Access for Dialysis

Minimally Invasive Ellipsys System Creates Fused, Permanent Vascular Access for Dialysis

In contrast, the Ellipsys System uses a small needle puncture and catheter to percutaneously establish an AVF without an implant or suture, leaving the vessels and tissue around the fistula undisturbed. ...

ByMedtronic


Medtronic to Acquire Avenu Medical

Medtronic to Acquire Avenu Medical

In contrast, Avenu Medical's Ellipsys® Vascular Access System is a single-catheter, ultrasound-guided device that inserts a catheter percutaneously (through the skin) into the arm to create a durable AV fistula. ...

ByMedtronic


New Study Shows Advantages of Ellipsys System in Safely and Quickly Creating Reliable Dialysis Access

New Study Shows Advantages of Ellipsys System in Safely and Quickly Creating Reliable Dialysis Access

A new study shows significant benefits of the Ellipsys Vascular Access System in easily and safely creating durable vascular access for end-stage renal disease (ESRD) patients who require hemodialysis. It also offers a standardized process for using the minimally invasive technology that other physicians can follow to reproduce the results, which “will make it easier for more practitioners ...

ByMedtronic


Q’Apel Medical announces first-in-human case with Wahoo.

Q’Apel Medical announces first-in-human case with Wahoo.

The Wahoo access catheter contains proprietary SelectFlex variable stiffness technology that allows the physician to control the level of flexibility or support that the catheter provides at any given moment during a clinical case. ...

ByQ`Apel Medical Inc.


Ellipsys System Offers Significant Advantages for Creating Dialysis Access, Physicians Say

Ellipsys System Offers Significant Advantages for Creating Dialysis Access, Physicians Say

The Ellipsys® Vascular Access System enables patients with kidney failure to start dialysis treatment sooner with fewer procedures, complications and interventions compared to surgery, according to several leading physicians who spoke at the recent meeting of the American Society of Diagnostic and Interventional Nephrology (ASDIN). Interventional radiologist Jeffrey Hull, M.D., was awarded ...

ByMedtronic


Two-year Ellipsys data featured at annual Controversies in Dialysis Access (CiDA) Meeting

Two-year Ellipsys data featured at annual Controversies in Dialysis Access (CiDA) Meeting

It creates an endovascular arteriovenous fistula (endoAVF) using just a small needle puncture and catheter. The multi-center study was included as part of a presentation during CiDA's "EndoAVF in Clinical Practice" session, as well during the "Ellipsys for EndoAVF®" industry symposium. ...

ByMedtronic


Adagio Medical Announces First Patient Enrollment in its iCLAS U.S. IDE Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Persistent Atrial Fibrillation

Adagio Medical Announces First Patient Enrollment in its iCLAS U.S. IDE Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Persistent Atrial Fibrillation

“This novel cryoablation system offers multiple advantages, including a single catheter to address all ablation needs, irrespective of whether right or left atrium is targeted for ablation, no 3D mapping required, and more comprehensive lesion sets may favorably impact long-term results of ablation in this difficult to treat patient population.” The ...

ByAdagio Medical, Inc.


Kardium® announces successful results from the GLOBAL-AF study

Kardium® announces successful results from the GLOBAL-AF study

The study demonstrated a 76% percent freedom from atrial fibrillation at 12 months after a single treatment with the Globe System. “I am very excited about the results from this first clinical experience with the Globe System,” said Prof. ...

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

There is a strong demand to treat this patient group with endocardial, continuous, transmural lesion sets with results similar to what has been shown with the surgical Maze procedure. Using a single iCLAS catheter, the procedure can be completed in less than one hour,” says Olav Bergheim, CEO of Adagio Medical, Inc. The 8.5Fr iCLAS ...

ByAdagio Medical, Inc.


Sofregen Receives 510(k) Clearance for Silk Voice - The First and Only Natural Silk Protein Injectable Product for Tissue Bulking

Sofregen Receives 510(k) Clearance for Silk Voice - The First and Only Natural Silk Protein Injectable Product for Tissue Bulking

This is the first and only FDA cleared product made from solubilized silk protein and is expected to significantly impact the treatment of this condition due to the unique material properties of silk protein scaffold and a proprietary single-use catheter delivery system. “The clearance of Silk Voice for Vocal Fold Medialization is an important milestone ...

BySofregen Medical Inc


SKI Vascular Center is First Ambulatory Surgical Center in the Nation to Utilize FDA-Approved Ellipsys System for Non-Surgical Dialysis Fistula Creation

SKI Vascular Center is First Ambulatory Surgical Center in the Nation to Utilize FDA-Approved Ellipsys System for Non-Surgical Dialysis Fistula Creation

The recently FDA-approved Ellipsys System is a minimally-invasive, single catheter-based system designed for ESRD patients requiring hemodialysis. ...

ByMedtronic

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