St. Jude Medical received CE Mark approval in Europe for its AMPLATZER Amulet Left Atrial Appendage Occluder for treating people with non-valvular atrial fibrillation (AF). Because blood clots in people with AF typically form in the left atrial appendage, closing it off has a distinct clinical advantage in preventing strokes.
The Amulet was based on the AMPLATZER Cardiac Plug, itself EU approved four years ago, but is designed to be implantable on a greater variety of patient anatomies.
From St. Jude:
The enhanced AMPLATZER Amulet design was driven by feedback from physicians who have been implanting the AMPLATZER Cardiac Plug in Europe since 2008. Self-expanding and made of braided Nitinol mesh, consistent with the entire family of AMPLATZER devices, the Amulet occluder works by blocking the LAA at its opening, which minimizes the opportunity for blood clots to form in the LAA or migrate into the bloodstream. This next-generation occlusion device is built with a longer lobe and waist than previous versions to allow for easier placement. The end screw is flush with the disc to create a smooth surface within the left atrium, and the larger disc diameter offers increased orifice coverage. 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.
Flashbacks: AMPLATZER Vascular Plug 4 for Tortuous Peripheral Vessels Gets Green Light in U.S.; CE Mark Given to AMPLATZER Vascular Plug III; AMPLATZER Cardiac Plug Gets European OK; Percutaneous VSD Patch Results Presented