Adagio Medical announced that it enrolled the first patient in its iCLAS investigational device exemption clinical trial for assessing the treatment for persistent atrial fibrillation. The iCLAS is a low-temperature intelligent continuous legion ablation system. The FDA-approved study has the goal of evaluating the safety and efficacy of the system in PsAF to support pre-market approval […]
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FDA OKs Adagio Medical’s cryoablation afib trial
Adagio Medical yesterday said it received an investigational device exemption from the FDA for a clinical trial of its cryoablation device for treating atrial fibrillation. The 80-patient study, a non-randomized, single-arm trial of subjects with persistent afib, will use the Laguna Hills, Calif.-based company’s intelligent continuous lesion ablation system to treat patients with afib of […]
Adagio Medical raises $7m
Cardiovascular cryoablation tech developer Adagio Medical has raised approximately $7 million in a new round of equity and options financing, according to a recently posted SEC filing. The company is looking to raise an additional $13 million, which would bring the total raised up to $20 million, according to the filing. Adagio Medical is developing and producing […]
Adagio Medical launches OneShot+ cardio cryoablation cath
Cardiovascular cryoablation tech developer Adagio Medical said it launched its One Shot+ cryoablation catheter, and that the first patient has been treated with the device. The Laguna Hills, Calif.-based company said the newly cleared One Shot+ catheter is intended for pulmonary vein isolation and other continuous ablation lesions of non-pulmonary-vein targets for treating atrial fibrillation. […]
