St Jude Medical launches new trial of Amplatzer cardiac plug

St Jude Medical has announced that the first patient has received an implant as part of its new clinical trial of the Amplatzer cardiac plug.

The company is assessing the device as a means of preventing blood clots from migrating out of the left atrial appendage in patients with non-valvular atrial fibrillation who have a high risk for stroke.

This prospective, randomised, multicentre clinical study features an adaptive trial design and will enrol between 400 and 3,000 patients across the US and Canada, with the aim of supporting the device's approval in America.

St Jude Medical has been selling the Amplatzer cardiac plug in Europe since 2008 and launched the Amplatzer Amulet left atrial appendage occluder earlier this year as a successor.

Frank Callaghan, president of St Jude Medical's cardiovascular and ablation technologies division, said: "This trial will help us understand the long-term benefits of LAA occlusion therapy for lowering the risk of stroke in atrial fibrillation patients and potentially improve their quality of life."

This week the company also announced the Japanese launch of the Ilumien Optis System, a 3D vessel reconstruction technology offering.