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Safety and Efficacy of the Indigo Aspiration System in Patients with Acute Pulmonary Embolism (EXTRACT-PE)

Robert A. Lookstein, MD, MHCDL, Mount Sinai, New York, New York, discusses the EXTRACT-PE trial results, evaluating the Indigo Aspiration System (Penumbra, Inc.) in patients with acute pulmonary embolism. The Indigo Aspiration System is a continuous aspiration mechanical thrombectomy system designed to remove clot from arteries and veins in the peripheral vasculature and for the treatment of pulmonary embolism.  EXTRACT-PE was a prospective, single-arm, multicenter trial, conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration. It evaluated the safety and efficacy of the Indigo Aspiration System in the treatment of acute pulmonary embolism (ClinicalTrials.gov Identifier NCT03218566), enrolling 119 participants across 22 U.S. study centers. 

 

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use: https://bit.ly/338bDv8.


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