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

Key Terms

premarket approval regulatory

Premarket approval is the formal regulatory clearance required before certain medical devices can be sold, based on detailed evidence that the product is safe and effective. For investors, it’s a major milestone because receiving approval typically clears the way for commercial sales and reduces regulatory uncertainty, while failure or delays can block revenue and raise the risk profile; think of it like a safety certificate needed before a new car model can be sold.

pma regulatory

PMA stands for Premarket Approval, the U.S. Food and Drug Administration’s highest-level review for high-risk medical devices. It’s a thorough evaluation to confirm a device is safe and effective before it can be sold, like a final safety inspection and license to operate. Investors care because receiving PMA can open a significant revenue stream, while delays or rejection can postpone sales and reduce a company’s value.

u.s. food and drug administration regulatory

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

ventricular tachycardia medical

A fast, abnormal heartbeat that starts in the heart’s lower chambers and can sharply reduce blood flow, potentially causing dizziness, fainting or, in severe cases, sudden collapse; picture an engine running so fast it loses power. For investors, ventricular tachycardia matters because demand for drugs, devices, diagnostic tests and emergency care tied to this condition affects clinical trial results, regulatory approvals, revenue prospects and legal or safety risks for healthcare companies.

anti-arrhythmic drug medical

A drug that restores or controls the heart’s normal rhythm by reducing or preventing irregular heartbeats; think of it as a metronome or reset button for the heart’s electrical timing. Investors watch these medicines closely because trial results, regulatory decisions, safety issues, and prescribing trends can rapidly change a company’s revenue outlook and risk profile, similar to how a single product can make or break sales for a tech firm.

electrophysiology medical

The study and measurement of the electrical signals that control cells and tissues, most commonly used to diagnose and treat heart rhythm problems and to test how nerves and muscles communicate. Investors care because electrophysiology drives products, procedures and drugs—like monitoring systems, catheter tools and implants—that can alter a medical device or drug maker’s sales, regulatory approvals and clinical trial outcomes; think of it as checking and fixing the wiring that makes the body run.

cardiomyopathy medical

A condition that weakens or stiffens the heart muscle, reducing its ability to pump blood effectively; think of the heart as an engine that becomes less powerful or less flexible. For investors, cardiomyopathy matters because it can drive demand for medical treatments, affect healthcare costs, influence the value of companies developing drugs or devices, and trigger regulatory or insurance impacts that change revenues and risks across the healthcare sector.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted

Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market

LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) in patients with ischemic or non-ischemic structural heart disease.

The PMA submission is supported by the FULCRUM-VT pivotal IDE trial, a single-arm study that enrolled 209 patients across 20 leading electrophysiology centers. The trial achieved 97.4% acute clinical success and demonstrated compelling 6-month outcomes, including 84.3% freedom from ICD shock, only 2.4% major adverse events and a 78% reduction or elimination of anti-arrhythmic drug (“AAD”) use. Importantly, vCLAS demonstrated equivalent clinical effectiveness in both ischemic and non-ischemic cardiomyopathy, addressing the largest unmet need in VT ablation today.

“The submission of our PMA application is a defining moment for Adagio Medical and, more importantly, for the hundreds of thousands of patients suffering from ventricular tachycardia who currently have no purpose-built solution,” said Todd Usen, Chief Executive Officer of Adagio Medical. “We believe FULCRUM-VT demonstrated that Adagio’s proprietary ULTA is not just a different approach to VT ablation – it is a fundamentally better solution, which achieved compelling outcomes across the metrics that matter most to physicians and patients: safety, freedom from ICD shock, reduction in AAD use, and consistent results across the broadest patient population ever studied in a VT ablation trial. Our endocardial-only approach has the potential to democratize VT ablation for electrophysiologists and offers physicians a purpose-built tool capable of treating every eligible VT patient — ischemic and non-ischemic alike — without compromise. We look forward to working closely with the FDA through the review process and are energized by the possibility of bringing this technology to a broad population of patients suffering from VT.”

About Adagio Medical Holdings, Inc.

Adagio is a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias utilizing its novel, proprietary, catheter-based Ultra-Low Temperature Ablation (“ULTA”, formerly known as ULTC) technology. ULTA is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue, all through an endocardial approach. The Company is currently focused on the treatment of ventricular arrhythmias with its purpose-built vCLAS™ Cryoablation System, which is CE Marked and is currently under evaluation in the Company’s FULCRUM-VT U.S. Pivotal IDE Trial.

About FULCRUM VT

FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm trial, which has fully enrolled 209 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance with current treatment guidelines. FULCRUM-VT 6-month primary chronic effectiveness was defined as freedom from sustained monomorphic VT lasting longer than 30 seconds or VT requiring appropriate ICD device therapy, in the absence of new or increase in antiarrhythmic drug therapy beyond previously failed dose.

Adagio’s vCLAS™ Cryoablation System is commercially available for the treatment of monomorphic VT in Europe and select other geographies but is limited to investigational use in the United States.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” “plans,” "potential," “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: anticipated timing and outcome of the FDA’s review of the Company’s PMA application for the vCLAS Ventricular Ablation System; the potential for FDA approval to lead to the broadest industry indication for purely endocardial ablation of scar-mediated VT; the potential for ULTA technology to address unmet needs in the treatment of VT, including across both ischemic and non-ischemic cardiomyopathy substrates; the potential clinical benefits of ULTA; the potential market opportunity for the vCLAS Ventricular Ablation System; and Adagio's research, development, regulatory and commercialization plans, including communications with the FDA. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission (“SEC”) filings, including in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 12, 2026 and which is available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260521192887/en/

Debbie Kaster
Chief Financial Officer and Chief Business Officer
dkaster@adagiomedical.com

Source: Adagio Medical Holdings, Inc