---
title: "Adagio Medical treats first patient with next-generation vCLAS Ultra ULTA system under FDA expanded access"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/294693443.md"
description: "Adagio Medical treated its first patient using the next-generation vCLAS Ultra ULTA system under FDA Expanded Access for ventricular tachycardia. The procedure succeeded in a patient with prior failed attempts, highlighting potential for hard-to-treat cases. Pre-clinical data suggests the single-freeze design may shorten procedures. Clinical results presented at Heart Rhythm 2026 showed favorable safety. An IDE expansion for the FULCRUM-VT pivotal trial was cleared ahead of expected decisions on the first-generation system."
datetime: "2026-08-03T12:31:24.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/294693443.md)
  - [en](https://longbridge.com/en/news/294693443.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/294693443.md)
generator: "portal-rs"
---

# Adagio Medical treats first patient with next-generation vCLAS Ultra ULTA system under FDA expanded access

-   Adagio Medical treated the first patient under FDA Expanded Access using its next-generation vCLAS Ultra ultra-low temperature ablation system for ventricular tachycardia. \* The procedure succeeded in a patient with prior failed ablation attempts, supporting the device’s potential in hard-to-treat cases near sensitive anatomy. \* Pre-clinical work indicates the single-freeze design could shorten procedures, a change that could improve lab throughput and adoption if replicated clinically. \* Clinical results were already presented at Heart Rhythm 2026 for the ULTA platform, showing a favorable safety profile and reduced arrhythmia-related interventions. \* FDA cleared an IDE expansion of the FULCRUM-VT pivotal trial to evaluate the next-generation system, ahead of an expected decision on the first-generation system in coming months. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Adagio Medical Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260803231067) on August 03, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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