Imperative Care’s Symphony Thrombectomy System Cleared for PE

September 2, 2025—Imperative Care, Inc. announced it has received FDA 510(k) clearance of its Symphony thrombectomy system to treat pulmonary embolism (PE). Symphony is a large-bore aspiration catheter system for clot removal designed to combine large-bore power with precise deep vacuum control, stated the company.

According to Imperative Care, the clearance for PE expands the use of Symphony, previously cleared for treatment of venous thrombosis, thereby providing a comprehensive solution for venous thromboembolism patients.

The company advised that the clearance follows the completion of the SYMPHONY-PE Study, announced in May 2025.

The pivotal investigational device exemption trial evaluated the safety and efficacy of Symphony for the treatment of acute PE and was led by Vivian L. Bishay, MD, and Sripal Bangalore, MD.

“The study data clearly demonstrate Symphony’s safety, efficacy, and efficiency, marking a significant advancement in the treatment of patients with PE,” commented Dr. Bishay in the company’s press release. “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.”

Dr. Bangalore added, “In the treatment of PE, reducing right heart strain is of critical importance. The more rapidly we can remove thrombus and restore stable hemodynamics, the greater the benefit for patients. 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.”