Sub-analysis presented at TCT 2026 shows substantial clot burden reduction and improved right-heart function with the Symphony Thrombectomy System despite greater baseline cardiac stress in women
CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, a medical technology company focused on advancing the treatment of thromboembolic disease, today announced new findings from a pre-specified sex-specific analysis of the SYMPHONY-PE IDE Trial, published simultaneously in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) and presented by Aymen Ahmed, MD, of Endeavor Health Cardiovascular Institute, at Transcatheter Cardiovascular Therapeutics (TCT) 2026. The analysis found that women and men with intermediate-risk pulmonary embolism (PE) experienced substantial clot burden reduction, improvements in right-heart function, and broadly comparable short-term clinical and safety outcomes following aspiration thrombectomy with the Symphony Thrombectomy System, despite women demonstrating greater evidence of cardiac stress at baseline with similar initial clot burden.
“Previous studies have raised concerns about higher rates of bleeding and vascular complications among women undergoing procedures requiring large-bore vascular access, including advanced pulmonary embolism interventions. These concerns make the safety and effectiveness of large-bore thrombectomy in women an important clinical question,” said Arman Qamar, MD, MPH, senior and corresponding author of the study, Director of the Center for Cardiovascular Personalized Medicine and Co-Director of the Pulmonary Embolism Response Team at Endeavor Health Cardiovascular Institute.
“Our findings are particularly encouraging. Despite presenting with greater evidence of cardiac stress at baseline, women experienced substantial reductions in clot burden and improvements in right ventricular function, with clinical and safety outcomes broadly comparable to those observed in men. These prospective findings provide reassurance regarding the use of 24F pump-driven aspiration thrombectomy in women, while underscoring the need for larger studies to further evaluate sex-specific treatment responses and long-term outcomes,” added Dr. Qamar.
The analysis evaluated procedural and effectiveness outcomes in a modified intention-to-treat (ITT) population of 106 patients across 17 U.S. centers, including 42 women (40%) and 64 men (60%). The 24F Symphony aspiration catheter was used in 91% of women and 94% of men. No deaths or device-related serious adverse events were reported in either group through 30 days. At 48 hours, women had significantly lower RV/LV ratios than men (1.03 vs. 1.14; P=0.006), a difference that remained significant after multivariable adjustment (P=0.010). Women experienced a greater unadjusted percentage reduction in mean pulmonary artery pressure than men (28% vs. 19%; P=0.02), although the association between sex and post-thrombectomy mean pressure was not statistically significant after adjustment.
“Generating meaningful clinical evidence is fundamental to advancing thrombectomy care,” said Fred Khosravi, Chairman and CEO of Imperative Care. “As the first-in-field sex-specific analysis of a 24F pump-driven aspiration thrombectomy platform, we believe these findings address an important evidence gap in the treatment of women with pulmonary embolism and reinforce our commitment to advancing clinical science that helps physicians make informed treatment decisions and ultimately improve patient care.”
About the SYMPHONY-PE IDE Trial
The SYMPHONY-PE IDE Trial (NCT06062329) was a prospective, multicenter, single-arm study evaluating the safety and efficacy of the Symphony Thrombectomy System in patients with acute intermediate-risk pulmonary embolism. The system incorporates continuous pump-driven aspiration with 24F and 16F catheter options. The trial enrolled 109 patients across 17 U.S. centers.
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, headquartered in Silicon Valley, is a medical technology company focused on advancing the treatment of thromboembolic disease. Its commercial portfolio spans stroke and vascular thrombectomy and includes the Zoom Stroke System, Symphony Thrombectomy System and Prodigy Thrombectomy System. Together, these technologies form an aspiration thrombectomy portfolio designed to enable physicians to remove blood clots across neurovascular and peripheral indications throughout the body, with a focus on improving procedural efficiency. Imperative Care is building on its established commercial platforms with the Telos Robotic Platform* to bring greater precision and standardization to procedures and expand access to lifesaving treatment.
Learn more at www.imperativecare.com.
*Currently in development. Not cleared or approved for use or available for sale.
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