Jupiter Endovascular, Inc. has recently announced groundbreaking results from its first-in-human (FIH) study of the Transforming Fixation (TFX) technology applied to the Vertex Pulmonary Embolectomy System. This innovative approach to treating acute, intermediate-risk pulmonary embolism (PE) could represent a significant advancement in endovascular interventions, particularly for patients who are typically underserved by current treatment modalities.
The SPIRARE I Study
Presented at the Transcatheter Cardiovascular Therapeutics (TCT 2025) conference by Professor Irene Lang, MD, the SPIRARE I study serves as a significant milestone for Jupiter Endovascular. The trial, registered under NCT06571760, was conducted across two specialized medical sites in Austria and Poland, with a specific focus on assessing the safety and efficacy of the Vertex system featuring TFX technology.
The study enrolled ten patients, showcasing the early promise of TFX in managing PE—a condition that poses severe risks to cardiovascular health. According to Professor Lang, TFX technology provides unparalleled stabilization and control during procedures, alleviating the historical limitations associated with device access and delivery.
Significant Findings
The results, which present an optimistic view of TFX technology, include:
- Zero Major Adverse Events: Remarkably, there were no major complications, including major bleeding, within the critical 48-hour post-procedure window.
- Procedural Efficacy: The vast majority, 80%, of interventions were performed without the need to re-cross the heart, and 70% did not require a stiff guidewire—two factors usually complicating such procedures.
- Cardiovascular Improvements: Patients experienced a 32% reduction in mean pulmonary artery pressure (mPAP), dropping from 30.8 mmHg to 20.8 mmHg.
- Better Ventricular Ratio: There was a notable 29% improvement in the mean right ventricle/left ventricle (RV/LV) ratio, significantly decreasing from 1.4 to 1.0 at 48 hours post-intervention.
- Enhanced Quality of Life: Patient-reported outcomes reflected substantial improvements in their dyspnea scores, with a 71% improvement on the modified Medical Research Council (mMRC) Dyspnea Scale at 48 hours, escalating to a remarkable 94% improvement at the 30-day mark.
Implications for PE Treatment
The implications of the SPIRARE I study are profound, particularly given that pulmonary embolism remains an area of significant unmet medical need. A substantial number of patients are still considered undertreated, leading to persistent symptoms and chronic conditions, including right heart failure. The innovations in TFX technology could potentially offer a pathway to more effective treatments, focusing not only on mitigating immediate risks but also addressing long-term health outcomes.
Charles Love, Chief Science Officer at Jupiter Endovascular, emphasized the importance of viewing cardiac function and clinical recovery as crucial metrics for treatment efficacy in pulmonary embolism. He noted that the SPIRARE I findings validate the potential therapeutic benefits of TFX technology from a cardiac-centric perspective. This approach signifies a paradigm shift in how pulmonary embolism treatment may be approached in the future.
Next Steps
With the encouraging findings from the SPIRARE I trial, Jupiter Endovascular is poised to advance into larger-scale studies, particularly the SPIRARE II pivotal trial, which will be conducted in both the U.S. and Europe. This ongoing research aims to confirm and expand upon the positive results achieved thus far, providing deeper insights into the safety and effectiveness of TFX technology across a broader patient demographic.
Conclusion
In summary, the recent results from the SPIRARE I study herald a promising future for Jupiter Endovascular and its TFX technology. With compelling evidence supporting improved procedural success, enhanced cardiac function, and better patient outcomes for those suffering from pulmonary embolism, there is a renewed sense of hope for advancing treatment modalities in this critical area. Ongoing trials will hopefully refine these findings, solidifying TFX’s role in reshaping the landscape of endovascular interventions.
To follow developments regarding TFX technology and the ongoing studies, interested readers can visit Jupiter Endovascular.
