St. Jude Medical has implanted the first patient in a clinical study of its Amplatzer Cardiac Plug (ACP) device, designed for the prevention of stroke in patients with non-valvular atrial fibrillation (AF).
The self-expanding occlusion device is made with nitinol mesh and is delivered via catheter to completely seal the left atrial appendage (LAA) at its opening and minimize blood clots from forming in the LAA and migrating into the bloodstream
The pivotal, investigational device exemption, prospective, randomized, multi-center Amplatzer Cardiac Plug clinical trial (ACP trial), with an adaptive trial design, will recruit up to 400 to 3,000 patients and compare the safety and efficacy of the device to traditional medical treatment using long-term, blood-thinning medication like warfarin.
The trial will also help to understand the long-term benefits of LAA occlusion therapy for potentially improving the quality of life in AF patients, claims the company.
St Jude Medical cardiovascular and ablation technologies division president Frank Callaghan said, "The AMPLATZER Cardiac Plug has shown great promise in international markets and we look forward to establishing the evidence required to make it available in the U.S."
The company said the ACP device is not approved for use in the US.
