Imperative Care today announced positive efficacy and safety results from its pivotal SYMPHONY-PE study.
SYMPHONY-PE evaluates the company’s Symphony thrombectomy system in the treatment of acute pulmonary embolism (PE).
Campbell, California-based Imperative Care designed Symphony, a large-bore aspiration catheter system, to deliver more efficient and effective clot removal. It combines large-bore power with deep vacuum control to help remove more clot in less time.
The system includes 16F and 24F catheters that enable smooth tracking and stability. The vacuum capabilities provide greater removal force compared to syringe-based and tubing-based systems, Imperative Care says.
Earlier this month, Imperative Care announced that it received FDA approval for Symphony in the treatment of PE. The clearance expanded the use of Symphony, which previously served as a treatment for venous thrombosis, to PE. It delivers a comprehensive solution for treating the full spectrum of venous thromboembolism (VTE) patient needs. PE, a life-threatening condition, occurs when blood clots block an artery in the lungs.
Today, the company reported the presentation of new study results backing Symphony at The PERT Consortium 2025 11th Annual Pulmonary Embolism (PE) Scientific Symposium in San Diego. Findings were published in Circulation: Cardiovascular Interventions.
“Symphony introduces a new category in venous thromboembolism (VTE) treatment with Pulse Thrombectomy – the unique combination of a large-bore catheter with powerful, continuous vacuum delivered closer to the clot. This technology, paired with a streamlined procedural technique, enables physicians to remove more clot in less time,” said Doug Boyd, SVP and GM of Imperative Care’s Vascular business. “We remain committed to building robust clinical evidence that validates our technologies and extends Symphony’s impact so more patients can receive life-saving care. We are deeply grateful to the patients, investigators, and clinical sites who helped make Symphony available across the U.S.”
A look at the findings from Imperative Care
Dr. Vivian L Bishay and Dr. Sripal Bangalore co-led the study as national co-principal investigators. Bishay is an associate professor in the Dept. of Diagnostic, Molecular and Interventional Radiology at the Mount Sinai Health System and Bangalore is a professor in the Dept. of Medicine at NYU Grossman School of Medicine.
The FDA investigational device exemption study evaluated 109 patients with acute intermediate-risk PE across 17 U.S. institutions.
In the trial, Symphony demonstrated a strong safety profile, high efficacy and procedural efficiency. Additionally, investigators saw no device-related serious adverse events (SAE). They reported marked clot-burden reduction, short device-use time and minimal blood loss.
Bishay reported significant improvements in right ventricle-to-left ventricle ratio, systolic and mean pulmonary artery pressures (PAP) and clot burden.
The study met its pre-specified primary efficacy and safety endpoints.
“These findings represent clinically meaningful progress in PE treatment, underscoring the device’s excellent safety profile,” Bishay said. “The ability to bring a large-bore catheter directly to the clot and safely deliver continuous aspiration marks an emerging paradigm shift in PE intervention. I look forward to the device’s continued impact in my practice.”
