FDA granted Breakthrough Device Designation for Adagio vCLAS cryoablation system.

 
Adagio Medical Holdings Inc 

ADGM-25.3%

+ Free Alerts

 shares are trading higher by 124% to $2.07 during Thursday’s session after the FDA granted Breakthrough Device Designation for the vCLAS cryoablation system.

 Adagio Medical says the system targets drug-resistant, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or non-ischemic structural heart disease. The device is designed to improve VT ablation safety and outcomes.

This designation grants Adagio priority FDA review and enhanced support during the premarket phase. It also reflects promising early data from Adagio's European CRYOCURE-VT study. The device is meanwhile under investigation in the U.S. through the FULCRUM-VT trial, enrolling 206 patients.


Adagio CEO Todd Usen called the designation a major milestone, citing unmet needs in VT treatment. While already approved in Europe, the device remains investigational in the U.S., with plans to pursue premarket approval following study completion.

https://www.benzinga.com/news/25/04/44870413/why-adagio-medical-holdings-adgm-stock-is-skyrocketing