Adagio Medical Holdings, Inc. (Nasdaq: ADGM; “Adagio Medical”,
“Adagio” or the “Company”), a leading innovator in catheter
ablation technologies, today announced the completion of the first
procedures in FULCRUM-VT U.S. Food and Drug Administration (FDA)
Pivotal IDE study of Adagio’s VT Cryoablation System. Procedures
were performed by Professor William G. Stevenson, MD, at Vanderbilt
University Medical Center in Nashville, TN and Dr. J. David
Burkhardt at Texas Cardiac Arrhythmias Institute (TCAI) at Austin,
TX.
FULCRUM-VT (Feasibility of Ultra-Low
Temperature Cryoablation in Recurring
Monomorphic Ventricular Tachycardia,
NCT05675865) is a prospective, multi-center, open-label, single-arm
study, enrolling 206 patients with structural heart disease of both
ischemic and non-ischemic cardiomyopathy, indicated for catheter
ablation of drug refractory ventricular tachycardia (VT) in
accordance with current treatment guidelines. The results of the
study will be used to obtain FDA premarket approval (PMA) for
Adagio’s VT Cryoablation System with the vCLAS™ cryoablation
catheter with industry broadest indication for purely endocardial
ablation of scar-mediated VT.
“Our center enrolled six patients in the Early Feasibility stage
of FULCRUM-VT program, with encouraging results,” said Dr.
Stevenson, a world-renowned expert in the treatment of cardiac
arrhythmias. “Today’s procedures mark the expansion of the program
to 20 centers in the US and Canada, allowing for the robust
evaluation of Adagio’s technology in a large and challenging
population of patients with structural heart disease. The only
approved ablation option we can currently offer these patients is
based on radiofrequency, or RF energy, which has well-known
limitations for ablations in thicker cardiac tissue and when
managing patients at risk of cardiac decompensation, the
limitations this system may help overcome.”
“This was TCAI’s first experience with Adagio’s system,” added
Dr. Burkhardt, “and we successfully and safely ablated a
non-ischemic scar in tissue with depth exceeding 10 mm in the
proximity of the artificial transcatheter aortic valve, which
limited the achievable depth of other available technologies. This
gives us confidence and motivation as we continue with study
enrollment.”
The Adagio Medical VT Cryoablation System with the vCLAS™
cryoablation1 catheter is based on the Company’s proprietary
ultra-low temperature cryoablation (ULTC) technology and was
designed specifically to address both safety and effectiveness
challenges of VT ablation by creating large and deep endocardial
lesions with minimal attenuation by scar tissue2 without the need
for catheter irrigation, a known risk for acute heart failure in
patients undergoing RF ablations. The system has recently gained
CE-Mark approval and is commercially available in select European
countries.
“We are pleased to partner with the top academic institutions to
bring a long-overdue innovation in VT ablation technology to
patients in the US,” said Olav Bergheim, President and CEO of
Adagio. “Just recently, FULCRUM-VT received Medicare coverage
approval from the Center for Medicare and Medicaid Services (CMS)
and study approval from Health Canada. We are now focused on
accelerating patient enrollment at all study sites. The European
launch of vCLAS is also accelerating, with a growing number of
centers evaluating ULTC technology across the spectrum of VT
etiologies and patient presentations.”
1The Adagio Medical, Inc. VT Cryoablation System (Catheter and
Console) is indicated for the treatment of monomorphic ventricular
tachycardia by ablation of arrhythmogenic tissues that drive and
maintain these arrhythmias. The vCLAS™ Cryoablation Catheter, a
component of the Adagio Medical, Inc. VT Cryoablation System is
intended to create transmural linear and focal lesions to cardiac
structures within the endocardium of the ventricles with
cryoablation. Adagio Medical, Inc. PM-006 Rev. E
2 Dewland TA, Higuchi S, Venkateswaran R, Lee C, Gerstenfeld EP.
AB-452672-2 Ultra-low Temperature Cryoablation Versus Ultra-low
Temperature Cryoablation Combined With Pulsed Field Ablation In A
Swine Ventricular Infarct Model. Heart Rhythm 2023;20:S92-S93.
https://doi.org/10.1016/j.hrthm.2023.03.395
About Adagio Medical
Adagio Medical, Inc. is an early commercial stage medical device
company located in Laguna Hills, California focusing on developing
innovative cryoablation technologies that create contiguous,
transmural lesions to treat cardiac arrhythmias, including
paroxysmal and persistent atrial fibrillation, atrial flutter, and
ventricular tachycardia.
Forward-Looking Statements
Certain statements in this press release may be considered
“forward-looking statements” within the meaning of the “safe
harbor” provisions of the United States Private Securities
Litigation Reform Act of 1995. Forward-looking statements generally
relate to future events or future financial or operating
performance of the Company. For example, any statements that refer
to expectations, projections or other characterizations of future
events or circumstances are forward-looking statements. In some
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forward-looking statements are subject to risks, uncertainties, and
other factors which may be beyond the control of the Company and
could cause actual results to differ materially from those
expressed or implied by such forward-looking statements. These
forward-looking statements are based upon estimates and assumptions
that, while considered reasonable by the Company and its
management, are inherently uncertain. The Company cautions you that
these statements are based on a combination of facts and factors
currently known and projections of the future, which are inherently
uncertain. There are risks and uncertainties described in the
definitive proxy/final prospectus relating to the Business
Combination, which was filed by the Company with the SEC, and
described in other documents filed by the Company from time to time
with the SEC. These filings may identify and address other
important risks and uncertainties that could cause actual events
and results to differ materially from those contained in the
forward-looking statements. The Company cannot assure you that the
forward-looking statements in this communication will prove to be
accurate.
Nothing in this Press Release should be regarded as a
representation or warranty by any person that the forward-looking
statements set forth herein will be achieved or that any of the
contemplated results of such forward-looking statements will be
achieved, in any specified time frame, or at all. You should not
place undue reliance on forward-looking statements, which speak
only as of the date they are made in this Press Release. Subsequent
events and developments may cause those views to change. The
Company does not undertake any duty to update these forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20241024585690/en/
Media Ilya Grigorov Vice President, Global Marketing and
Product Management Adagio Medical Holdings, Inc.
igrigorov@adagiomedical.com Investors
IR@adagiomedical.com
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