The device is used to prevent embolization of thrombi in the LAA, thus preventing the occurrence of ischemic stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation.
Angiografia de Occidente interventional cardiologist Bernardo Caicedo said the percutaneously delivered device promises to offer a safe and effective alternative for atrial fibrillation patients who cannot take long-term oral anticoagulants and have limited options to reduce their stroke risk.
"It incorporates a pre-loaded device that is both repositionable and retrievable to enhance its ease of use," Caicedo said.
The company said in the multi-center, randomized Protect AF clinical trial, the device proved to be non-inferior to long-term warfarin therapy.
Boston is currently enrolling US patients in the Prevail study in order to receive US Food and Drug Administration (FDA) approval.
