Imperative Care’s Symphony Thrombectomy System Shows Promise in Acute PE Treatment

Imperative Care Inc. is sharing positive efficacy and safety results from a trial evaluating its Symphony Thrombectomy System in treating acute pulmonary embolism (PE).

Results of the SYMPHONY-PE Trial were published in Circulation: Cardiovascular Interventions in a paper titled “A Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial.”

In the trial, Symphony demonstrated a strong safety profile, high efficacy, and procedural efficiency. Notably, there were no device-related serious adverse events (SAE), with marked clot-burden reduction, short device-use time, and minimal blood loss.

The prospective Investigational Device Exemption (IDE) trial evaluated 109 patients with acute intermediate-risk PE across 17 U.S. institutions. The trial was led by national co-principal investigators Vivian L. Bishay, M.D., associate professor in the Department of Diagnostic, Molecular, and Interventional Radiology at the Mount Sinai Health System, and Sripal Bangalore, M.D., professor in the Department of Medicine at NYU Grossman School of Medicine and lead peer-reviewed paper author.

“The trial results demonstrated significant improvements in right ventricle–to–left ventricle (RV/LV) ratio, systolic and mean pulmonary artery pressures (PAP), and clot burden, with no device-related SAE and no mortality reported at 30 days,” Dr. Bishay said. “These findings represent clinically meaningful progress in PE treatment, underscoring the device’s excellent safety profile. 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.”

“Rapid thrombus removal using large-bore mechanical thrombectomy has the potential to improve patient hemodynamics, relieve right-heart strain, and reduce short-term morbidity and mortality in PE,” Dr. Bangalore added. “The excellent safety and efficacy demonstrated in this trial, together with short device-use times and minimal blood loss, underscore Symphony’s ability to address a critical unmet need by combining the advantages of large-bore continuous aspiration with the exceptional safety of real-time vacuum control.”

The trial met its pre-specified primary efficacy and safety endpoints, with results demonstrating:

• Efficacy: the core laboratory independently adjudicated a mean RV/LV 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 < 0.001).
• Safety: the independent safety board adjudicated the major adverse event (MAE) rate, a composite of all-cause major bleeding, device-related deaths, and device-related SAE rate within 48 hours of the procedure, at 0.9 % (1/109). The 97.5% upper confidence interval bound (5.7 %) was significantly lower than the 15% performance goal (p < 0.001).

“Symphony demonstrated an exceptional ability to deliver immediate and sustained objective and subjective improvements, achieving a 12 mmHg reduction in systolic pulmonary artery pressure and a 7 mmHg reduction in mean pulmonary artery pressure after aspiration, along with a 38.4% decrease in clot burden at 48 hours—all with a notably short device-use time and no safety concerns,” stated Dr. Dana Tomalty, M.D., peripheral and neuro interventional radiologist at Huntsville Hospital and the highest trial enroller. “These results appear to set a new benchmark for efficiency and safety in PE intervention. I am eager to bring this technology into routine clinical practice to improve outcomes for patients with acute PE.”

The Symphony Thrombectomy System is an aspiration catheter system engineered to deliver more efficient and effective clot removal in patients with venous thromboembolism (VTE). Symphony combines large-bore power with precise deep vacuum, giving physicians full control to remove more clot in less time. By delivering continuous deep vacuum closer to the clot, Symphony generates a Deep Pulse, a powerful pulse of aspiration that provides greater clot removal force compared to each of a syringe-based and tubing-based system¹ and minimal blood loss.² The system includes 16F and 24F catheters for smooth tracking, stability, and telescoping to reach distal anatomy; ProHelix Mechanical Assist designed to facilitate clot ingestion when needed; the Symphony 24F Advance Long Dilator for navigating through tortuous anatomy; and the Imperative Care Generator, one of the most powerful aspiration pumps available on the market1. The Symphony Thrombectomy System received U.S. Food and Drug Administration 510(k) clearance in August for pulmonary embolism treatment.

“Symphony introduces a new category in venous thromboembolism (VTE) treatment with Pulse Thrombectomy—the 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,” noted Doug Boyd, senior vice president and general manager 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 grateful to the patients, investigators, and clinical sites who helped make Symphony available across the U.S.”

Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by vascular diseases such as stroke and pulmonary embolism. The company is focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey. Imperative Care is based in Campbell, Calif. 

References
¹ Data on file.
² Data from SYMPHONY-PE IDE Trial.