Abbott (NYSE:ABT) announced today that it received CE mark and Health Canada approval for its Amplatzer steerable delivery sheath.
The company touts the Amplatzer sheath as the first steerable delivery sheath to be developed specifically for minimally invasive left atrial appendage (LAA) occlusion (or closure) procedures for patients diagnosed with atrial fibrillation who are at risk of ischemic stroke, according to a news release.
Abbott Park, Ill.-based Abbott designed the sheath for use with its Amplatzer Amulet LAA occluder. The company said the sheath also features bi-directional steering and an auto-lock setting for more accurate alignment with the LAA.
Additionally, the sheath includes a hemostasis valve designed to stabilize blood flow and minimize blood loss during the procedure. Abbott said the new design reduces the need for catheter manipulation or exchanges, thus reducing issues that slow down procedures or cause further blood loss.
FDA has not yet approved the Amplatzer sheath for use in the U.S.
Montreal Heart Institute’s Dr. Réda Ibrahim, who performed one of the first global procedures with the system, said in the release that the Amplatzer Amulet has “long been the LAA occlusion device of choice in Europe and Canada” for reducing stroke risk and removing the need for blood-thinning medications in those with AFib. Hence, the newly enhanced delivery system offers speedier procedure time and improved efficiency.
“This innovation advances the performance of our Amplatzer Amulet device and offers patients a much-needed treatment option to help manage stroke risk from atrial fibrillation,” SVP of Abbott’s structural heart business Michael Dale said in the release. “At Abbott, we are continually looking for new and better ways to address structural heart diseases, and this approval is another step forward in helping people achieve better health.”