EU bureaucrats have issued AGA Medical, a company from Plymouth, MN, the CE Mark of Approval for the AMPLATZER Cardiac Plug, a nitinol device designed for closure or occlusion of cardiac structures not involving the septal wall, such as nonsurgical closure of the left atrial appendage in patients with atrial fibrillation.
More about the product:
The AMPLATZER® Cardiac Plug is designed to provide optimal occlusion with full cross-sectional orifice coverage, flexible braided Nitinol mesh, and controlled, precise deployment. The Cardiac Plug has the ability to be repositioned, if necessary.
The lobe of the AMPLATZER Cardiac Plug is designed to conform to the inner wall of a cardiac structure with a depth of 10mm or more and provide secure device placement. Positional forgiveness is achieved through a waist that acts as an articulating, compliant connection between the disc and lobe allowing the disc to self-orient to the cardiac wall. The disc is designed to completely cover the orifice of the cardiac structure and provide apposition against the chamber wall under gentle tension…
“The ACP is an important addition to the interventional tools we have for structural heart repair. The design and conformability of the device as well as its ease of deliverability will allow us to effectively occlude challenging anatomy such as the left atrial appendage,” said Bernhard Meier, MD, FACC, FESC, professor and chairman of cardiology, University Hospital, Bern, Switzerland. “Scientific data suggests a strong link between atrial fibrillation and formation of thrombus in the left atrial appendage, which can increase the risk of stroke to 5 percent per year. Physicians have limited options to minimize stroke risk other than anticoagulants which are often associated with adverse side effects.”
Made of flexible braided Nitinol mesh, the ACP is designed to provide occlusion with full cross-sectional coverage. The ACP self-orients to the cardiac wall, covering the hole of the structure to be occluded. It leverages the proven microscrew technology platform used in all AGA Medical devices to provide physicians with simple, controlled and precise delivery. This allows the ACP to be recaptured and repositioned if necessary, ensuring a customized delivery and fit for each patient’s unique anatomic structure.
Press release: AGA Medical Receives European CE Mark Approval for AMPLATZER® Cardiac Plug – Device will enable minimally-invasive transcatheter closure of cardiac structures …
Product page: AMPLATZER® Cardiac Plug …
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