Adagio Medical seeks FDA PMA for ventricular ablation system

The application draws on data from the FULCRUM-VT pivotal IDE trial, which enrolled 209 patients across 20 centres.

Adagio Medical Submits Premarket Approval Application to FDA for vCLAS® Ventricular Ablation System for the Treatment of Ventricular Tachycardia

Adagio Medical Holdings, Inc (Nasdaq: ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation ...

Adagio Files PMA for Breakthrough Ventricular Ablation System

The latest announcement is out from Adagio Medical Holdings ( (ADGM) ).
MassDevice

Adagio submits ventricular ablation system to FDA

Adagio Medical (Nasdaq:ADGM) announced today that it submitted its premarket approval (PMA) application to the FDA for its ...

Medtronic (MDT) Highlights Affera Momentum and FDA Breakthrough Device Designation

On April 26, 2026, Medtronic announced continued momentum for the Affera family of technologies for cardiac arrhythmia treatment, including promising data presented at the Heart Rhythm Society (HRS) ...
Medical Xpress

First-in-human study demonstrates reduction of hard-to-reach ventricular tachycardias

Cryocure-VT was a first-in-human clinical trial evaluating the safety and efficacy of ULTC for the treatment of recurrent monomorphic VTs in patients with ischemic and non-ischemic cardiomyopathies.
TCTMD

Ultralow-Temperature Cryoablation Promising for Monomorphic VT

BERLIN, Germany—Treatment of monomorphic ventricular tachycardia (VT) with a novel ultralow-temperature cryoablation catheter (vCLAS; Adagio Medical) appears to be safe and effective in patients with ...
WBOC

Adagio Medical Announces Positive Pivotal Results for vCLAS® Ventricular Ablation System

Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today reported six month ...
Medscape

Antitachycardia Pacing for Ventricular Tachycardia Using Implantable Cardioverter Defibrillators

Sustained monomorphic VT in nonischemic dilated cardiomyopathy (NDCMP) is less common than in ischemic cardiomyopathy. The pathophysiological basis for sustained monomorphic VT associated with NDCMP ...