Imperative Care Presents Symphony Thrombectomy System Pivotal Trial in Acute PE

September 18, 2025—Imperative Care, Inc. announced efficacy and safety results from the pivotal SYMPHONY-PE trial. The prospective, multicenter investigational device exemption study is evaluating the company’s next-generation Symphony precision aspiration thrombectomy system in the treatment of acute intermediate-risk pulmonary embolism (PE).

The trial was composed of 109 patients with acute intermediate-risk PE at 17 centers in the United States. Vivian L. Bishay, MD, and Sripal Bangalore, MD, served as National Coprincipal Investigators of the study.

The SYMPHONY-PE trial results were presented by Dr. Bishay in a late-breaking session at The PERT Consortium’s 11th annual Pulmonary Embolism Scientific Symposium and simultaneously published by Dr. Bangalore et al in Circulation: Cardiovascular Interventions.

According to the company, the Symphony device demonstrated a strong safety profile, high efficacy, and procedural efficiency. There was marked reduction in clot burden, short device-use time, minimal blood loss, and no device-related serious adverse events, noted the company.

Imperative Care stated that the trial met its prespecified primary efficacy and safety endpoints, with the following findings:

• Efficacy: The core laboratory independently adjudicated a mean right ventricle/left ventricle reduction of 0.44 ± 0.42 from baseline to 48 hours. The lower bound of the 97.5% confidence interval (0.36) exceeded the prespecified performance goal of > 0.20 (P < .001).
• Safety: The independent safety board adjudicated a 0.9 % rate (1/109) of major adverse events, a composite of all-cause major bleeding, device-related deaths, and device-related serious adverse events rate within 48 hours of the procedure. The 97.5% upper confidence interval bound (5.7 %) was significantly lower than the 15% performance goal (P < .001).

Imperative Care recently announced FDA 510(k) clearance of the Symphony thrombectomy system to treat PE. The large-bore aspiration catheter system for clot removal is designed to combine large-bore power with precise deep vacuum control, noted the company.