Nov. 3, 2026 – Imperative Care has announced new findings from a pre-specified sex-specific analysis of the SYMPHONYPE 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.
Pulmonary Embolism Risk
The analysis found that women and men with intermediaterisk 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 intentionto-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.”
The SYMPHONY-PE IDE Trial
The SYMPHONY-PE IDE Trial (NCT06062329) was a prospective, multicenter, singlearm 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.
November 03, 2026 
