Sex-Specific Analysis of SYMPHONY-PE Trial Evaluates Imperative Care’s Thrombectomy System

November 3, 2026—Imperative Care announced new findings from a prespecified sex-specific analysis of the SYMPHONY-PE investigational device exemption trial. Aymen Ahmed, MD, presented the findings at TCT 2026 and simultaneously published the data in JSCAI.

According to Imperative Care, 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 after aspiration thrombectomy with the company’s Symphony thrombectomy system, despite women demonstrating greater evidence of cardiac stress at baseline with similar initial clot burden.

As summarized in the company’s press release, the analysis evaluated procedural and effectiveness outcomes in a modified intention-to-treat population of 106 patients (women, n = 42; men, n = 64) across 17 centers in the United States. The 24-F Symphony aspiration catheter was used in 91% of women and 94% of men. Through 30 days, no deaths or device-related serious adverse events were reported in either group.

The 48-hours data showed the following:

• Women had significantly lower right ventricular/left ventricular ratios than men (1.03 vs 1.14; P = .006), a difference that remained significant after multivariable adjustment (P = .01).
• Women experienced a greater unadjusted percentage reduction in mean pulmonary artery pressure than men (28% vs 19%; P = .02), although the association between sex and postthrombectomy mean pressure was not statistically significant after adjustment.

Arman Qamar, MD, senior and corresponding author of the study, commented on the findings in the company’s press release.

“Previous studies have raised concerns about higher rates of bleeding and vascular complications among women undergoing procedures requiring large-bore vascular access, including advanced PE interventions,” stated Dr. Qamar. “These concerns make the safety and effectiveness of large-bore thrombectomy in women an important clinical question.”

Dr. Qamar continued, “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 24-F pump-driven aspiration thrombectomy in women, while underscoring the need for larger studies to further evaluate sex-specific treatment responses and long-term outcomes.”