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February 3, 2020

FDA Approves CATALYST Trial Comparing Abbott’s Amplatzer Amulet LAA Occluder Versus NOACs

February 3, 2020—Abbott announced that the FDA has approved the CATALYST trial, which is designed to assess the company’s Amplatzer Amulet left atrial appendage (LAA) occluder for patients with atrial fibrillation (AF) who are at risk of stroke.

According to the company, the global, multicenter CATALYST trial will compare the effectiveness of the Abbott Amplatzer Amulet to nonvitamin K antagonist oral anticoagulants (NOACs) as an alternative treatment option in an expanded population of AF patients. Delivered to the heart transfemorally, the Amplatzer Amulet device allows physicians to permanently “seal off” the LAA.

The CATALYST trial will randomize up to 2,650 patients at 150 sites worldwide to assess whether sealing off the LAA with the Amulet device may be a viable alternative to a lifetime of these newer blood thinners. The risk of bleeding events, medication expenses, narrow therapeutic window, patient lifestyle, and medication compliance often limit blood thinner effectiveness in clinical practice, noted the company.

The Amplatzer Amulet device received European CE Mark approval in 2013 and is available in Europe and other countries that recognize CE Mark. In the United States, the device is for investigational use only.

Vivek Reddy, MD, the Principal Investigator for the CATALYST trial commented in Abbott’s announcement, “A device that can address a significant structural issue of the heart via a minimally invasive procedure would be a significant step forward for patients with AF eligible for long-term NOAC therapy. This study is an extremely important step in assessing the Amplatzer Amulet as an effective nonprescription drug alternative for patients with AF who are at an increased risk for ischemic stroke.” Dr. Reddy is Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital in New York, New York.

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