Penumbra’s IDE trial for acute PE successfully meet primary endpoints

Pulmonary embolism (PE) is a condition in which one or many pulmonary arteries in the lungs get blocked by blood clots. It can cause serious problems, like low oxygen in the blood and damage a patient’s lungs. Several global firms are increasingly working towards the development of effective treatment for PE. Penumbra, Inc. is one such company focused on innovative therapies, and has reportedly announced that its EXTRACT-PE trial has successfully met primary endpoints, demonstrating the efficacy and safety of Indigo® Aspiration System for mechanical thrombectomy in patients who are suffering from acute PE. The results of the clinical trial were represented in Late-Breaking clinical trial sessions at VIVA (Vascular InterVentional Advances) annual meeting in Las Vegas. According to Akhilesh Sista, MD, FAHA, FSIR, EXTRACT-PE principal investigator and chief of Vascular and Interventional Radiology at NYU-Langone School of Medicine, the positive result of this clinical trial is a vital step in developing required clinical evidence for catheter-based embolectomy treatments to treat patients with PE. According to the American Heart Association (AHA) guidelines, catheter-based embolectomy could play a vital role in the treatment of severe PE. EXTRACT-PE is a vital first step to determine when and how one should employ innovative and promising catheter-based technologies like the Indigo aspiration device. Reportedly, EXTRACT-PE was a single-arm, prospective, multicenter clinical trial carried out under Investigational Device Exemption (IDE) from the FDA (Food and Drug Administration) that determined the efficacy and safety of the Indigo Aspiration System in the treatment PE. As per Adam Elsesser, Chairman & CEO, Penumbra, the Indigo Aspiration System has shown tremendous potential to address patients with clot in other parts of the body. Elsesser claims that pulmonary embolism is a deadly disease with unmet clinical need and patient opportunity, and their firm is excited about the excellent results of this trial. He further Penumbra is looking forward to working with physicians in the field to bring better treatment options to patients. Source Credit - https://investors.penumbrainc.com/investors-relations/press-releases/press-release-details/2019/Penumbra-Indigo-Aspiration-System-IDE-Trial-for-Acute-Pulmonary-Embolism-Meets-Primary-Safety-and-Efficacy-Endpoints/default.aspx