Ultra-low temperature ablation system iCLAS developer Adagio Medical has secured an investigational device exemption approval from the US Food and Drug Administration (FDA) to conduct a non-randomized, single-arm clinical study for persistent atrial fibrillation (AF).
The study is expected to support the pre-market approval application for the treatment of patients with AF persisted for more than seven days but less than twelve months, and with no prior AF ablation therapy.
In addition, the company is planning to conduct the study in research centres that includes both private practice and academic sites across the US, Canada, and Europe.
Adagio chief executive officer Olav Bergheim said: “The Adagio procedure aims to improve current outcomes, reduce the procedure time and improve the profitability of the provider.
“Our recent press release dated July 31, 2019, regarding the use of anatomical markers only in the treatment of AF, including PsAF announced an important step in that direction. The Adagio iCLAS procedure is a transformational approach to AF ablation.”
Adagio to use One Shot and the One Shot+ cryoablation catheters in the study
Adagio said that the study marks the use of its cryoablation console with the One Shot and the One Shot+ cryoablation catheters.
In addition, it has designed the catheters to create continuous, transmural linear and focal lesions in the left and right atria.
Under the study, patients would receive an ablation with one of the two catheters and followed for 12 months for evidence of a recurrence of the arrhythmia.
Adagio regulatory affairs and quality vice president Nabil Jubran said: “Adagio has been working diligently toward, and is extremely pleased with, this important corporate milestone.
“We have started the approval process of our clinical sites and may have patients enrolled and treated by the fall. We are pleased with the strong interest expressed by the clinical community in participating in this clinical study.”
According to the company, a similar clinical study conducted in Europe has demonstrated the single treatment of patients with persistent AF reaching 90% efficacy one year after treatment using standard endpoint measurements for AF ablation.
