St Jude Medical receives CE Mark for stroke prevention device

St Jude Medical has been granted European CE Mark accreditation for a new device for use in the closure of the left atrial appendage in patients diagnosed with non-valvular atrial fibrillation (AF).

The Amplatzer Left Atrial Appendage Occluder is a next-generation percutaneous transcatheter device that helps prevent the risk of blood clot formation and release, thus reducing the risk of stroke – a key concern among AF patients.

It builds on the success of the original Amplatzer Cardiac Plug with additional features covering a wider range of appendage anatomies, such as a longer lobe and waist, a range of size options and the fact it comes pre-loaded into the delivery catheter.

Frank Callaghan, president of the cardiovascular and ablation technologies division at St Jude Medical, said: "Feedback from implanting physicians who have used our first-generation product has been instrumental to improving an already successful device."

This comes after the company received European regulatory clearance for its ViewFlex Xtra intracardiac echocardiography catheter last week.