Imperative Care has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Symphony Thrombectomy System to treat pulmonary embolism (PE).
Symphony has previously received clearance for the treatment of venous thrombosis.
Symphony Thrombectomy SystemImage courtesy of Imperative Care
Symphony Thrombectomy System is a large-bore aspiration catheter system for clot removal in patients with venous thromboembolism. The system can be telescoped to reach distal anatomy and includes 16F and 24F catheters, as well as the ProHelix Mechanical Assist tool designed to facilitate clot ingestion when necessary, a dilator, and an aspiration pump.
This clearance follows the successful completion of the SYMPHONY-PE study, an investigational device exemption trial evaluating the safety and efficacy of Symphony for the treatment of acute PE. The study was conducted under the oversight of Vivian L. Bishay, MD, associate professor in the Department of Diagnostic, Molecular, and Interventional Radiology at Mount Sinai Health System in New York, and Sripal Bangalore, MD, professor in the Department of Medicine at NYU Grossman School of Medicine in New York.
