Adagio Medical (ADGM) said Thursday it has received breakthrough device designation from the US Food and Drug Administration for its vCLAS cryoablation system.
The system is intended to treat ventricular tachycardia in people with ischemic or non-ischemic structural heart disease, the company said.
The FDA's breakthrough device program is intended to allow patients and healthcare providers to get more timely access to select medical devices, Adagio said.
Adagio Medical shares were 160% higher in recent trading.
Price: 2.45, Change: +1.57, Percent Change: +180.17
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