Imperative Care, a medical technology company focused on advancing treatments for patients suffering from thromboembolic disease, today announced findings from a post-hoc analysis of the SYMPHONY-PE Trial evaluating the effect of early mechanical thrombectomy in patients with intermediate-risk pulmonary embolism (PE). The analysis was published in Circulation: Cardiovascular Interventions in a paper titled “Is There a Golden Hour for Thrombectomy in Intermediate-Risk Pulmonary Embolism? Insights from SYMPHONY-PE.”1
Imperative Care also announced that more than 500 pulmonary embolism (PE) patients in the U.S. have been treated with the Symphony Thrombectomy System, reflecting growing physician adoption and commercial momentum since its market introduction in September 2025.
“We set out to establish a new standard in PE treatment by developing a large-bore system that removes the guesswork from thrombectomy and is designed to enable more efficient procedures and real-time decision-making so physicians can focus on what matters most: the patient,” said Fred Khosravi, Imperative Care’s Chairman and CEO. “Now, with more than 500 PE patients treated since commercial launch, we are encouraged by the growing physician confidence in Symphony and the continued clinical evidence supporting its procedural efficiency and favorable safety profile.”
“Behind this milestone are hundreds of patients and families affected by PE, and we are grateful to the patients and physicians who have placed their trust in Symphony as they work to deliver timely, life-saving care,” Khosravi added.
SYMPHONY-PE Trial Analysis Findings
The analysis of data from the SYMPHONY-PE Trial suggests that treating patients within 12 hours of diagnosis may be associated with greater improvement in acute hemodynamic and right ventricle measures compared to treatment after 12 hours, with similar safety outcomes between groups.
“While thrombectomy can be beneficial for patients with intermediate-risk PE regardless of when it is performed after diagnosis, data from the SYMPHONY-PE Trial add to the growing body of observational evidence2,3 suggesting that earlier catheter-based intervention may accelerate cardiac recovery, as reflected by greater reductions in right ventricle-to-left ventricle (RV/LV) ratio and mean pulmonary artery pressure (PAP),” said Sripal Bangalore, M.D., M.H.A., lead author of the paper and Professor in the Department of Medicine at NYU Grossman School of Medicine. “Randomized controlled trials are desirable to determine optimal treatment timing and to identify whether patients with certain risk factors are more likely to benefit from early intervention than others.”
The SYMPHONY-PE Trial was Imperative Care’s IDE study conducted at 17 U.S. sites that formed the basis for Symphony’s FDA clearance to treat PE in August 2025. Results of the IDE trial were published in the November 2025 issue of Circulation: Cardiovascular Interventions.4
In this analysis, patients enrolled in SYMPHONY-PE were divided into two groups based on time from diagnostic computed tomography pulmonary angiography to mechanical thrombectomy: early treatment defined as <12 hours, and late treatment defined as ≥ 12 hours. Early thrombectomy was performed in 44% (48/109) of patients.
The results demonstrated:
Efficacy
- Mean PAP decreased more in patients receiving early thrombectomy compared to patients receiving late treatment (8.6 vs. 5.8), reaching nominal statistical significance (p=0.006).
- Patients treated early experienced a larger reduction in RV/LV ratio from baseline to 48 hours compared to patients treated later (0.52 vs. 0.37; p=0.071).
- Differences in efficacy outcomes were greatest in higher-risk patients as assessed by the Composite Pulmonary Embolism Shock (CPES) score.
- Overall, repeat traversal of the right heart with the Symphony Thrombectomy System was required in only 4.6% (5/109) of cases — two in the early treatment window and three in the late treatment window.
Safety
- No significant difference in major adverse events (MAEs) within 48 hours between early and late thrombectomy groups. There was one MAE in the early treatment group and no MAEs in the late treatment group.
- No device-related serious adverse events (SAEs) and no deaths were reported in either group.
About the Symphony Thrombectomy System
The Symphony Thrombectomy System is a large-bore aspiration system designed to remove the guesswork from thrombectomy procedures, enabling more efficient, effective clot removal in patients with venous thromboembolism (VTE). Through real-time visualization inside the catheter and vessel, Symphony is designed to give physicians immediate insight into what is happening at every step of the procedure so they can make the right next move with confidence. 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 and avoid pulling a corked catheter across the heart when needed; the Symphony 24F Advance® Long Dilator for navigating through tortuous anatomy; and the Imperative Care Generator, a powerful aspiration pump.
For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: http://bit.ly/3pAaUlw.
About Imperative Care, Inc.
Imperative Care is a commercial-stage medical technology company focused on advancing treatments for patients suffering from thromboembolic disease, a serious medical condition caused by blood clot formation inside veins and arteries. Imperative Care was founded with the mission of bringing lifesaving treatments to patients suffering from ischemic stroke and other devastating vascular diseases caused by blood clot formation. The company’s commercially available product portfolio includes the Zoom Stroke System, the Symphony Thrombectomy System and the Prodigy Thrombectomy System. In addition to our commercial products, we are developing the Telos robotic platform*, an endovascular robotic system designed to bring greater precision and standardization to procedures and expand access to lifesaving treatment. Imperative Care is based in Campbell, Calif. Learn more at www.imperativecare.com.
- Bangalore, et al., “Is There a Golden Hour for Thrombectomy in Intermediate-Risk Pulmonary Embolism? Insights from SYMPHONY-PE.” Circulation: Cardiovascular Interventions. 2026;e016573.
- Zhang, et al., “Impact of Time to Catheter-Based Therapy on Outcomes in Acute Pulmonary Embolism, Circulation: Cardiovascular Interventions. 2025;18:e014499
- Leiva, et al. “Early versus delayed catheter-based therapies in patients hospitalized with acute pulmonary embolism”, EuroIntervention. 2025;21:e463-e470
- Bangalore, et al. “Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial.” Circulation: Cardiovascular Interventions. 2025;e015815.
*Currently in development. Not approved for use or available for sale.
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