Jupiter Endovascular, Inc. today announced publication of full results from its SPIRARE II pivotal trial evaluating the Vertex™ Thrombectomy System in patients with acute, intermediate-risk pulmonary embolism (PE), in the latest issue of EuroIntervention. The trial met all primary and secondary endpoints at 48 hours, with sustained symptom improvement through 30 days, in a patient population of elevated clinical severity. The publication builds on topline data first presented at EuroPCR 2026, adding complete clinical methodology, patient severity breakdowns, and invasive physiologic outcomes.
The Vertex system leverages the company’s proprietary Transforming Fixation (TFX) platform technology, a single catheter designed to navigate flexibly through the right heart and stabilize on-demand in the pulmonary arteries for precise, controlled intervention. This ability to combine flexible navigation and stable support in one catheter addresses long-standing challenges in PE thrombectomy related to cardiac strain and reliable vessel access.
The study evaluated a patient population where 85% of patients were classified as intermediate-high risk by ESC 2019 criteria. In a post-hoc analysis applying the 2026 AHA/ACC multi-society PE guidelines, 54% met the criteria for normotensive cardiogenic shock, a state in which normal blood pressure can mask underlying hemodynamic compromise and delay recognition, potentially increasing procedural risk.
SPIRARE II Results
Primary Endpoints:
- 0.39 mean reduction in RV/LV ratio at 48 hours (95% CI: 0.33, 0.45; p<0.0001)
- 2.4% major adverse event (MAE) rate (3/123; p<0.0001)
TFX-enabled thrombectomy with the Vertex system delivered meaningful afterload reduction, rapid right heart recovery, and durable symptom relief:
- Direct Hemodynamic Normalization: 29% reduction in mean pulmonary artery pressure (mPAP, −8.5 ± 6.3 mmHg), the directly measured invasive endpoint, with 50% of all patients reaching complete mPAP normalization (≤20 mmHg).
- Pulmonary Vascular Relief: 29% reduction in systolic pulmonary artery pressure (sPAP, −14.2 ± 10.5 mmHg) and a 26% reduction in total pulmonary vascular resistance (TPVR, –1.7 ± 2.3 Wood units).
- Sustained Symptom Improvement: 85% relative reduction in severe or very severe dyspnea (modified Medical Research Council grade), dropping from 58% of patients at baseline to 8% at 48 hours and 3% at 30 days.
Treatment characteristics reflected an efficient, minimally invasive procedure, with 100% technical success and zero use of adjunctive thrombolytics:
- 83% of cases did not require re-crossing of the pulmonic valve
- 39% of cases did not require a super-stiff guidewire
- 28.5-minute mean thrombectomy time (± 15.8)
“In a growing landscape of PE technology and research, we designed SPIRARE II to provide a more comprehensive look at the effect of PE treatment on a patient’s recovery,” said Catalin Toma, MD, Director of Interventional Cardiology at the UPMC Heart and Vascular Institute, Global Co-Principal Investigator of SPIRARE II and current Chief Medical Officer of Jupiter Endovascular. “PE is fundamentally a cardiovascular disease, not just an obstructed vessel, and patient recovery is determined by hemodynamic normalization and restoration of right heart function. That’s why we designed SPIRARE II to measure the full invasive hemodynamic profile by paired right heart catheterization in every patient, alongside independent core laboratory assessment of imaging and independent adjudication of every safety event. This assessment allowed us a physiologic view of how the device performs rather than relying on surrogate imaging or unadjudicated, site-reported outcomes.”
“SPIRARE II underscores the importance of device mechanics in achieving meaningful clinical outcomes,” said Sameh Sayfo, MD, Pulmonary Embolism Response Team Director at Baylor Scott & White The Heart Hospital – Plano and Global Co-Principal Investigator of SPIRARE II. “Rapid normalization of hemodynamics, while maintaining safe right-heart navigation and procedural stability, has remained a key challenge in PE thrombectomy. 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.”
“The publication of our SPIRARE II data in EuroIntervention reflects the dedication of the investigators and clinical teams,” said Carl J. St. Bernard, Chief Executive Officer of Jupiter Endovascular. “These results give us a strong foundation, and future post hoc analyses will help us better understand what drives recovery. Beyond this milestone, we see meaningful opportunity to extend our TFX platform to other complex cardiovascular anatomies, where stable access and precise, controlled intervention remain an unmet clinical need.”
About the SPIRARE II Trial
SPIRARE II (NCT06576427) is a prospective, single-arm, multicenter pivotal trial that enrolled 123 patients treated by 33 interventionalists of varied experience across 19 sites in the U.S. and Europe. The trial evaluated right heart functional improvement, clinical outcomes and safety of PE treatment with the Vertex system, with imaging endpoints assessed by an independent, blinded core laboratory and all adverse events adjudicated by an independent clinical events committee.
About the Vertex™ Thrombectomy System and TFX Technology
Key Benefits of Jupiter Endovascular’s Thrombectomy System
Understanding the Impact of Jupiter Endovascular’s Thrombectomy System
The Vertex Thrombectomy System leverages Jupiter Endovascular’s proprietary Transforming Fixation (TFX) platform technology to navigate flexibly through the right heart and transform on-demand into a stabilized state in the pulmonary arteries for precise, controlled intervention. TFX’s unique capability to decouple flexible navigation from stable support addresses long-standing challenges in pulmonary embolism thrombectomy related to cardiac strain, guidewire reliance, and reliable vessel access—enabling the system to achieve afterload relief and hemodynamic recovery alongside clot removal.