SPIRARE II Results Published for Jupiter’s Vertex Thrombectomy System

October 20, 2026—Jupiter Endovascular, Inc. announced that the full results of the SPIRARE II pivotal trial, evaluating the company’s Vertex thrombectomy system in patients with acute, intermediate-risk pulmonary embolism (PE), were published in EuroIntervention by Sameh Sayfo, MD, et al.

According to the company, SPIRARE II met all primary and secondary endpoints at 48 hours, with symptom improvement sustained through 30 days. The trial demonstrated a 39% mean reduction in right ventricular/left ventricular ratio at 48 hours (95% CI, 0.33-0.45; P < .0001) and a 4% major adverse event rate (P < .0001). The published findings expand on topline results presented at EuroPCR 2026 in May.

Jupiter reported that 85% of enrolled patients were classified as having intermediate-high–risk PE according to 2019 European Society of Cardiology criteria. In a post hoc analysis applying the 2026 American Heart Association/American College of Cardiology multisociety PE guidelines, 54% met criteria for normotensive cardiogenic shock.

The Vertex system uses Jupiter’s transforming fixation (TFX) platform, designed to provide flexible navigation through the right heart and on-demand catheter stabilization in the pulmonary arteries. The company reported 100% technical success without adjunctive thrombolytics. In 83% of procedures, recrossing the pulmonic valve was unnecessary, and 39% did not require a superstiff guidewire. Mean thrombectomy time, measured from first to final aspiration, was 28.5 ± 15.8 minutes.

Hemodynamic outcomes included a 29% reduction in mean pulmonary artery pressure (-8.5 ± 6.3 mm Hg), with 50% of patients achieving normalization (≤ 20 mm Hg). Systolic pulmonary artery pressure decreased by 29% (-14.2 ± 10.5 mm Hg), and total pulmonary vascular resistance decreased by 26% (-1.7 ± 2.3 Wood units). Severe or very severe dyspnea, assessed using the modified Medical Research Council grade, decreased from 58% of patients at baseline to 8% at 48 hours and 3% at 30 days.

“SPIRARE II underscores the importance of device mechanics in achieving meaningful clinical outcomes,” commented Dr. Sayfo in the press release. “Rapid normalization of hemodynamics, while maintaining safe right-heart navigation and procedural stability, has remained a key challenge in PE thrombectomy.”

Dr. Sayfo, who is Global Coprincipal Investigator of SPIRARE II, continued, “With more than half of patients in this study presenting with normotensive cardiogenic shock, a population at heightened procedural risk, it is encouraging to see immediate restoration of hemodynamics with improvements sustained over time. These findings highlight the potential of this technology to rapidly restore cardiopulmonary function in patients with acute PE.”