Abbott Wins Approval for CATALYST Trial for At-Risk Stroke Patients

This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AFib who are at an increased risk for ischemic stroke." In an email sent to MD+DI, Abbott wrote, “We already have an Amulet IDE trial underway that is intended to support our submission for approval in the U.S. for Amplatzer Amulet. The newly announced CATALYST trial will support our submission for an expanded indication for Amulet as a safe and effective alternative to NOAC drugs for patients with atrial fibrillation and at risk of stroke.” Abbott added, “In the U.S. alone, AFib prevalence is projected to increase from 5.2 million in 2010 to 12.1 million cases in 2030. With our Amplatzer Amulet device, we hope to provide physicians with an alternative option for their patients with AFib and potentially eliminate the need for blood thinners long-term.” Abbott inherited the Amplatzer through the $25 billion acquisition of St. Jude Medical. The Amplatzer Amulet device received CE Mark approval in 2013. The Amplatzer Amulet (LAA) occlusion device has been shown at one year to reduce stroke by 57% as compared to the predicted stroke risk. The data also showed it was able to make this reduction without the need for lifetime blood thinners. Abbott released this data at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventi...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory and Compliance Source Type: news

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