Adagio Medical Receives FDA Breakthrough Designation for vCLAS Cryoablation System.

Adagio Medical Holdings has received FDA Breakthrough Device designation for its vCLAS Cryoablation System, accelerating the review process for treating drug-resistant ventricular tachycardia, a life-threatening heart rhythm disorder. This innovation has the potential to significantly impact patients with structural heart disease, providing a more effective treatment option.

Adagio Medical Holdings, Inc. (Nasdaq: ADGM) has received FDA Breakthrough Device designation for its vCLAS Cryoablation System, accelerating the review process for treating drug-resistant ventricular tachycardia (VT), a life-threatening heart rhythm disorder. This designation, granted by the U.S. Food and Drug Administration (FDA), recognizes the potential of the vCLAS system to provide significant benefits to patients with structural heart disease.

The vCLAS Cryoablation System is designed to address the limitations of traditional radiofrequency (RF) ablation technologies, which can be ineffective in thicker cardiac tissue and in patients at risk of cardiac decompensation. Adagio's proprietary ultra-low temperature cryoablation (ULTC) technology enables the creation of large and deep endocardial lesions with minimal attenuation by scar tissue, without the need for catheter irrigation, a known risk for acute heart failure in patients undergoing RF ablations.

The FULCRUM-VT study, a prospective, multi-center, open-label, single-arm study enrolling 206 patients with structural heart disease, is currently underway to evaluate the safety and effectiveness of the vCLAS system. The study aims to obtain FDA premarket approval (PMA) for the system, which has recently gained CE-Mark approval and is commercially available in select European countries.

The FULCRUM-VT study received Medicare coverage approval from the Center for Medicare and Medicaid Services (CMS) and study approval from Health Canada, further accelerating the system's commercial launch in the U.S. and Canada.

Adagio Medical's CEO, Olav Bergheim, stated, "We are pleased to partner with top academic institutions to bring a long-overdue innovation in VT ablation technology to patients in the U.S. Just recently, FULCRUM-VT received Medicare coverage approval from CMS and study approval from Health Canada. We are now focused on accelerating patient enrollment at all study sites."

The vCLAS Cryoablation System's potential to offer a more effective treatment option for patients with structural heart disease and drug-resistant VT has significant implications for the healthcare industry. As the system progresses through clinical trials and regulatory approvals, it could become a transformative tool in the management of this life-threatening condition.

References:
1. [1] https://www.businesswire.com/news/home/20241024585690/en/Adagio-Medical-Announces-Completion-of-First-Procedures-in-FULCRUM-VT-U.S.-FDA-Pivotal-IDE-of-Ventricular-Tachycardia-Cryoablation-System