FDA OKs Imperative Care’s Symphony Thrombectomy System for Pulmonary Embolism

Imperative Care has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Symphony thrombectomy system to treat pulmonary embolism (PE).

The clearance expands Symphony’s use—previously to treat venous thrombosis—to now include PE. The company said this offers a comprehensive solution to treat the full spectrum of venous thromboembolism (VTE) patient needs.

Symphony is a large-bore aspiration catheter system designed to more efficiently and effectively provide clot removal for VTE patients. It combines large-bore power with precise deep vacuum control, with 16F and 24F catheters that allow for smooth tracking and stability and can be telescoped to rich distal anatomy.

The company said delivering deep vacuum closer to the clot provides greater clot removal compared to both syringe-based and tubing-based systems without increased blood loss. The system also includes the ProHelix mechanical assist tool to facilitate clot ingestion when needed, the Symphony 24 Advace long dilator to navigate through tortuous anatomy, and the Imperative Care Generator aspiration pump.

The FDA nod follows successful finish of the SYMPHONY-PE study, a pivotal IDE trial evaluating Symphony’s safety and efficacy in treating acute PE. The study was led under the oversight of the National Co-Principal Investigators, Dr. Vivian L. Bishay, M.D., Associate Professor in the Department of Diagnostic, Molecular and Interventional Radiology at Mount Sinai Health System in New York, and Dr. Sripal Bangalore, M.D., M.H.A., 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 Dr. 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.”

“At Imperative Care, our approach to innovation begins by identifying the most impactful problems in patient care and engineering solutions that elevate long-term outcomes of patients,” added Fred Khosravi, Chairman and CEO of Imperative Care. “Pulmonary embolism can have a devastating impact on patients’ lives, irreversibly and within minutes. We remain fully committed to transforming the treatment of thrombo-embolic diseases for patients and providing physicians with technologies that make clot removal safer, easier and more effective. This achievement would not have been possible without the patients and their families who selflessly participated in the pivotal trial, and we are deeply grateful to the investigators and research teams whose tireless dedication turned the vision of this new therapy into a reality for patients with pulmonary embolism.”

Earlier this summer, the company earned FDA clearance for the Zoom 7X catheter for aspiration thrombectomy procedures.