Adagio Medical Holdings, Inc. Receives FDA Breakthrough Device Designation for the vCLASTM Cryoablation System
Adagio Medical Holdings (Nasdaq: ADGM) has received FDA Breakthrough Device designation for its vCLAS™ Cryoablation System, designed to treat drug-refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with ischemic or non-ischemic structural heart disease.
The system utilizes proprietary Ultra-Low Temperature Cryoablation (ULTC) technology and is currently under evaluation in the FULCRUM-VT IDE study, enrolling 206 patients. The study's results will support FDA premarket approval application, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT.
The Breakthrough Device designation provides priority review and enhanced communication with the FDA during the premarket review phase. The vCLAS™ system is already commercially available in Europe and select geographies but remains to investigational use in the United States.
Adagio Medical Holdings (Nasdaq: ADGM) ha ottenuto la designazione FDA Breakthrough Device per il suo sistema di crioablazione vCLAS™, progettato per trattare la tachicardia ventricolare monomorfa sostenuta, ricorrente e resistente ai farmaci, in pazienti con cardiopatia strutturale ischemica o non ischemica.
Il sistema utilizza la tecnologia proprietaria di crioablazione a ultra-bassa temperatura (ULTC) ed è attualmente in fase di valutazione nello studio FULCRUM-VT IDE, che coinvolge 206 pazienti. I risultati dello studio supporteranno la domanda di approvazione pre-mercato FDA, potenzialmente portando all'indicazione più ampia nel settore per l'ablazione endocardica pura della tachicardia ventricolare mediata da cicatrici.
La designazione Breakthrough Device garantisce una revisione prioritaria e una comunicazione migliorata con la FDA durante la fase di revisione pre-mercato. Il sistema vCLAS™ è già disponibile in Europa e in alcune aree geografiche selezionate, ma negli Stati Uniti è ancora riservato all'uso sperimentale.
Adagio Medical Holdings (Nasdaq: ADGM) ha recibido la designación de Dispositivo Innovador (Breakthrough Device) de la FDA para su sistema de crioablación vCLAS™, diseñado para tratar la taquicardia ventricular monomórfica sostenida, recurrente y resistente a medicamentos en pacientes con cardiopatía estructural isquémica o no isquémica.
El sistema utiliza tecnología propietaria de crioablación a ultra baja temperatura (ULTC) y actualmente se encuentra en evaluación en el estudio FULCRUM-VT IDE, que incluye a 206 pacientes. Los resultados del estudio respaldarán la solicitud de aprobación previa a la comercialización de la FDA, lo que podría conducir a la indicación más amplia de la industria para la ablación endocárdica pura de taquicardia ventricular mediada por cicatrices.
La designación Breakthrough Device ofrece revisión prioritaria y una comunicación mejorada con la FDA durante la fase de revisión previa a la comercialización. El sistema vCLAS™ ya está disponible comercialmente en Europa y en algunas regiones seleccionadas, pero en Estados Unidos sigue siendo de uso investigacional.
Adagio Medical Holdings (나스닥: ADGM)는 약물에 반응하지 않는 재발성 지속 단형 심실빈맥 치료를 위해 설계된 vCLAS™ 크라이오어블레이션 시스템에 대해 FDA 혁신 의료기기 지정(Breakthrough Device designation)을 받았습니다. 이 환자들은 허혈성 또는 비허혈성 구조적 심장질환을 가지고 있습니다.
이 시스템은 독자적인 초저온 크라이오어블레이션(ULTC) 기술을 사용하며, 현재 206명의 환자를 모집 중인 FULCRUM-VT IDE 연구에서 평가 중입니다. 연구 결과는 FDA 시판 전 승인 신청을 지원할 예정이며, 흉터 매개 심실빈맥에 대한 순수 내막 절제술로서 업계에서 가장 광범위한 적응증을 확보할 가능성이 있습니다.
혁신 의료기기 지정은 시판 전 심사 단계에서 우선 검토와 FDA와의 향상된 소통을 제공합니다. vCLAS™ 시스템은 이미 유럽과 일부 특정 지역에서 상업적으로 이용 가능하지만, 미국에서는 아직 임상 연구용으로만 사용되고 있습니다.
Adagio Medical Holdings (Nasdaq : ADGM) a obtenu la désignation de dispositif médical innovant (Breakthrough Device) de la FDA pour son système de cryoablation vCLAS™, conçu pour traiter la tachycardie ventriculaire monomorphe soutenue, récurrente et résistante aux médicaments chez les patients atteints de cardiopathie structurelle ischémique ou non ischémique.
Ce système utilise une technologie propriétaire de cryoablation à ultra-basse température (ULTC) et fait actuellement l’objet d’une évaluation dans l’étude FULCRUM-VT IDE, qui inclut 206 patients. Les résultats de l’étude soutiendront la demande d’autorisation de mise sur le marché auprès de la FDA, pouvant mener à l’indication la plus étendue du secteur pour l’ablation endocardique pure des TV médiées par cicatrices.
La désignation Breakthrough Device offre un examen prioritaire et une communication renforcée avec la FDA durant la phase d’évaluation pré-commercialisation. Le système vCLAS™ est déjà disponible commercialement en Europe et dans certaines régions sélectionnées, mais reste à usage expérimental aux États-Unis.
Adagio Medical Holdings (Nasdaq: ADGM) hat die FDA Breakthrough Device-Zertifizierung für sein vCLAS™ Cryoablation System erhalten, das zur Behandlung von medikamentenresistenter, rezidivierender, anhaltender monomorpher ventrikulärer Tachykardie bei Patienten mit ischämischer oder nicht-ischämischer struktureller Herzerkrankung entwickelt wurde.
Das System nutzt die firmeneigene Ultra-Low Temperature Cryoablation (ULTC)-Technologie und wird derzeit in der FULCRUM-VT IDE-Studie mit 206 Patienten evaluiert. Die Studienergebnisse werden die FDA-Zulassungsanfrage vor dem Inverkehrbringen unterstützen und könnten zur branchenweit breitesten Indikation für die rein endokardiale Ablation von narbenvermittelter VT führen.
Die Breakthrough Device-Zertifizierung ermöglicht eine priorisierte Prüfung und eine verbesserte Kommunikation mit der FDA während der Zulassungsphase. Das vCLAS™-System ist bereits in Europa und ausgewählten Regionen kommerziell erhältlich, in den USA jedoch noch für die experimentelle Nutzung vorgesehen.
- FDA Breakthrough Device designation received, enabling priority review and faster potential market access
- System already commercially available in Europe and select markets
- Large-scale FULCRUM-VT study with 206 patients underway
- Potential for broadest industry indication for endocardial ablation of scar-mediated VT
- Product still to investigational use in the US market
- FDA approval timeline remains uncertain despite Breakthrough designation
- Successful completion of FULCRUM-VT study required before potential FDA approval
Insights
FDA Breakthrough Device designation significantly accelerates Adagio's regulatory pathway for its VT treatment device, enhancing market potential and validating its technology.
The FDA's Breakthrough Device designation for Adagio's vCLAS™ Cryoablation System represents a significant regulatory milestone that legitimizes their novel approach to treating ventricular tachycardia. This designation is particularly noteworthy as it covers both ischemic and non-ischemic structural heart disease patients – potentially positioning Adagio for the broadest indication in the VT ablation market.
Regulatory advantages are substantial: priority review status and enhanced interactive communication with the FDA during the premarket review phase will likely accelerate the approval timeline. To qualify for this designation, Adagio had to demonstrate that their technology addresses a life-threatening condition and offers significant advantages over existing alternatives – a noteworthy validation of their Ultra-Low Temperature Cryoablation approach.
The ongoing FULCRUM-VT IDE pivotal study enrolling 206 patients will be crucial for their PMA submission. With the technology already commercially available in Europe, clinical evidence from their CRYOCURE-VT study likely supported their breakthrough application. While this designation doesn't guarantee approval, it significantly strengthens Adagio's regulatory position and indicates FDA recognition of the unmet need their technology addresses. The timeline from designation to potential approval typically ranges from 12-24 months, assuming positive clinical results, positioning Adagio for potential US market entry significantly faster than the traditional pathway.
Adagio's cryoablation technology represents a significant clinical advance for treating life-threatening ventricular tachycardia with potential for improved safety and effectiveness.
Ventricular tachycardia represents one of the most challenging cardiac arrhythmias to treat effectively. Traditional radiofrequency ablation approaches have significant limitations in creating transmural lesions that fully penetrate scarred ventricular tissue, leading to high recurrence rates of approximately
Adagio's Ultra-Low Temperature Cryoablation (ULTC) technology offers a compelling clinical advantage by creating deeper, more durable lesions that extend through both diseased and healthy cardiac tissue. This is particularly valuable for treating scar-mediated VT where arrhythmogenic substrate often exists deep within ventricular tissue.
The FDA's recognition through Breakthrough designation validates what many electrophysiologists have observed – that current treatment options for drug-refractory VT in structural heart disease patients remain suboptimal. This technology could address a significant unmet need in a patient population that experiences substantial morbidity and mortality.
The fact that Adagio's system is indicated for both ischemic and non-ischemic cardiomyopathy is clinically significant, as non-ischemic patients often have midmyocardial or epicardial substrates that are difficult to reach with conventional approaches. The creation of larger, transmural lesions could improve first-procedure success rates and reduce the need for repeat ablations or escalation to more invasive surgical approaches. For patients suffering from recurrent VT episodes despite medication, this represents a potentially transformative treatment option that could significantly improve quality of life and reduce mortality risk.
Agency’s Breakthrough Device Designation Program Allows for Priority Review of Ablation Technology for Ventricular Tachycardia
The FDA Breakthrough Device Program, which reflects the FDA’s commitment to device innovation and protecting public health, is intended to help patients and health care providers receive more timely access to select medical devices. To be eligible for Breakthrough Device designation, a device must meet two criteria set by the FDA. First, the device must have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Second, the device must also meet at least one of the following: it must represent breakthrough technology, there must be no approved or cleared alternative, the device must offer significant advantages over existing approved or cleared alternatives, and/or device availability must be in the best interest of patients.
Under the program, the FDA will provide Adagio with priority review and interactive communication during the vCLASTM Cryoablation System premarket review phase.
“Receiving Breakthrough Device Designation is an important milestone for Adagio, validating our proprietary vCLASTM Cryoablation System with our ULTC technology as a potentially unique solution for the large, underserved population of patients suffering from ventricular tachycardia,” said Todd Usen, Chief Executive Officer of Adagio. “Our team has been working hard to bring this transformational technology to patients, and we are thrilled to be the only technology to be granted Breakthrough Device designation for endocardial treatment of both ischemic and nonischemic structural heart disease patients with sustained monomorphic VT. We are encouraged that, based in part on the strength of the clinical data from our European CRYOCURE-VT study, the FDA has determined that vCLASTM qualifies as a Breakthrough Device, and we look forward to working collaboratively with the agency to make the vCLASTM System available to
VT is a rapid, abnormal heart rhythm, or arrhythmia, that originates in the heart's lower chambers, or ventricles, leading to blood flow issues and significant symptoms. If sustained, VT can become fatal.
FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) 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 VT in accordance with current treatment guidelines. The results of the study will be used to apply for FDA premarket approval (PMA) for Adagio’s vCLAS™ Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT.
Adagio’s vCLASTM Cryoablation System is commercially available for the treatment of monomorphic ventricular tachycardia in
About Adagio
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 Cryoablation (ULTC) technology. ULTC is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue. The Company is currently focused on the treatment of ventricular tachycardia (VT) with its purpose-built vCLASTM Cryoablation System which is CE Marked and is currently under evaluation in the Company’s FULCRUM-VT
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,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding: the vCLASTM Cryoablation System FULCRUM-VT IDE clinical trial, as well as the timing and outcome of any results therefrom, potential FDA approval, or potential launch or commercialization in
View source version on businesswire.com: https://www.businesswire.com/news/home/20250417165046/en/
Debbie Kaster
Adagio Medical
IR@adagiomedical.com
Source: Adagio Medical Holdings, Inc.
FAQ
What is the significance of FDA Breakthrough Device designation for Adagio Medical's (ADGM) vCLAS system?
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What is the target condition for Adagio Medical's (ADGM) vCLAS Cryoablation System?
