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 more than one week but less than a year, who have not previously had ablation therapy.
The primary safety endpoints are procedural adverse events at one day, seven days, 30 days and one year; the primary efficacy endpoints are the rate of complete pulmonary vein isolation, termination of afib and complete linear block if applicable, all at one day.
Adagio said the 12-month study is slated to treat patients with one of two types of cryoablation catheter, its One Shot or One Shot+ devices.
“The Adagio procedure aims to improve current outcomes, reduce the procedure time and improve the profitability of the provider,” CEO Olav Bergheim said in a release. “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.”
The study will utilize sites in the U.S., Canada and Europe. Adagio “may have patients enrolled and treated by the fall,” vice president of regulatory affairs & quality Nabil Jubran said in prepared remarks.