CE Mark For St.Jude’s Amplater™ Amulet™ LAA Occluder

In short

St. Jude Medical, Inc., used last week’s Boston AF symposium to trumpet the news that it has gained European 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 (AF).

Background

According to research, AF leads to an increased risk for stroke. The involvement of the LAA as the site where clots are formed in AF patients has been established, with the anatomical feature reportedly being the source of something like 90% of them. Sealing off the LAA helps prevent the risk of blood clot formation and release, potentially reducing the risk of stroke. This may also avoid the need for a lifetime of blood thinning drugs with their own attendant issues.

St.Jude says its next-generation percutaneous transcatheter device leverages the design and clinical success of the original Amplatzer™ Cardiac Plug,  building on feedback from physicians who have been implanting it in Europe since 2008. In particular, additional features allow treatment of a wider range of appendage anatomies, eight sizes now being available. The new 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.

Additionally, the device is pre-loaded into the delivery catheter, which simplifies device preparation and ultimately streamlines the entire procedure for the physician.

Company comments

“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.”

U.S. regulatory status

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

Source: St.Jude Medical, Inc., Business wire

Image courtesy Business Wire