St Jude Medical receives the CE mark for the Amplatzer Amulet Left Atrial Appendage Occluder for stroke prevention


St Jude Medical has announced it has received CE mark approval of its Amplatzer Amulet Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation.

According to a company release, the next-generation percutaneous transcatheter device leverages the design and clinical success of the original Amplatzer Cardiac Plug with additional features allowing treatment of a wider range of appendage anatomies. The new self-expanding device is made of braided Nitinol mesh, the Amulet occluder works by blocking the LAA at its opening, which minimises the opportunity for blood clots to form in the LAA or migrate into the bloodstream.

The company states that the enhanced Amplatzer Amulet design was driven by feedback from physicians who have been implanting the Amplatzer Cardiac Plug in Europe since 2008.

The Amplatzer Amulet device is offered in eight sizes to accommodate varying anatomies. Additionally, the device is pre-loaded into the delivery catheter, which simplifies device preparation and ultimately streamlines the entire procedure for the physician.

“Feedback from implanting physicians who have used our first-generation product has been instrumental to improving an already successful device,” said Frank J Callaghan, president of the Cardiovascular and Ablation Technologies Division.

“We are pleased to offer a next-generation LAA occluder that addresses a wider range of patient anatomies, is easier to implant, and has the potential to further reduce the incidence of stroke in AF patients.”

This new device was unveiled at 18th annual Boston AF Symposium (17–19 January 2013).

The Amplatzer Amulet Left Atrial Appendage Occluder is not yet approved for use in the United States.