Imperative Care has today announced Food and Drug Administration (FDA) 510(k) clearance of its Symphony thrombectomy system to treat pulmonary embolism (PE).
This clearance expands the use of Symphony—previously for the treatment of venous thrombosis—to now include PE, providing a comprehensive solution to effectively and efficiently treat the full spectrum of venous thromboembolism (VTE) patient needs.
The clearance follows the successful completion of the SYMPHONY-PE study, a pivotal investigational device exemption (IDE) trial evaluating the safety and efficacy of Symphony for the treatment of acute PE. The study was led under the oversight of the national co-principal investigators, 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, professor in the Department of Medicine at NYU Grossman School of Medicine in New York.
“The study data clearly demonstrate Symphony’s safety, efficacy and efficiency, marking a significant advancement in the treatment of patients with pulmonary embolism,” said Bishay. “These results underscore Symphony’s potential to address a critical unmet need by enabling rapid, controlled clot removal while maintaining a strong safety profile. I look forward to incorporating this important new technology into my practice to improve care for patients facing this life-threatening condition.”
“In the treatment of pulmonary embolism, reducing right heart strain is of critical importance. The more rapidly we can remove thrombus and restore stable haemodynamics, the greater the benefit for patients,” said Bangalore. “Based on my initial clinical experience with the Symphony thrombectomy system, I believe it has the potential to advance clinical practice by merging large-bore continuous aspiration with the safety and precision of real-time vacuum control.”
