Jupiter Endovascular today announced positive results from the first-in-human study of its Vertex pulmonary embolectomy system.
SPIRARE I evaluates the Vertex system featuring transforming fixation (TFX) technology in patients with acute, intermediate-risk pulmonary embolism (PE). Vertex incorporates Jupiter’s novel technology into an endovascular procedure. It designed the technology to treat acute pulmonary embolism (PE) with control and precision.
Vertex delivery takes place in a flexible, relaxed state over a guidewire to a target location in the vasculature. Rapidly pressurized with saline, it fixes in a stable position for intervention. Then, it returns to a relaxed state to navigate to another target location or for removal. The system received FDA investigational device exemption in August 2024.
Jupiter won FDA clearance for its Vertex catheter incorporating TFX last month, then announced $40 million in funding weeks later.
Dr. Irene Lang, principal investigator, presented findings for Vertex at the 2025 Transcatheter Cardiovascular Therapeutics conference in San Francisco.
Menlo Park, California-based Jupiter describes SPIRARE I as the first study to evaluate the safety and performance of Vertex. The prospective, multi-center European study enrolled 10 patients across two sites in Austria and Poland.
Findings included zero major adverse events, including major bleeding, within 48 hours. Jupiter said that 80% of procedures took place without re-crossing the heart. Investigators completed 70% of procedures without the use of a stiff guidewire.
Patients had a 32% improvement in mean pulmonary artery pressure (mPAP). It decreased intraprocedurally from 30.8 mmHg to 20.8 mmHg. Additionally, the company reports a 29% improvement in mean right ventricle/left ventricle (RV/LV) ratio at 48 hours post-procedure. Investigators also saw a 71% improvement in mean modified Medical Research Council (mMRC) Dyspnea Scale at 48 hours (2.4 points) and 94% improvement at 30 days (3.2 points).
Commentary from investigators and Jupiter leadership
Lang, who serves as a professor of vascular biology at the Medical University of Vienna, said:
“TFX represents an entirely new way to perform endovascular interventions, overcoming the long-standing tradeoff between device access and delivery. Pulmonary embolism remains an area of major unmet need — both in the acute phase and over the long term — where its sequelae may contribute to chronic heart failure. The exceptional stability and control provided by TFX have the potential to enable substantial unloading of the right heart and hemodynamic normalization. In this study, the vast majority of procedures were completed without the need to re-cross the heart or use a stiff guidewire, and the data demonstrated an excellent safety profile with marked improvements in right heart function and overall clinical recovery. Together, these findings underscore the promise of this technology for pulmonary embolism and cardiovascular disease.”
Charles Love, Jupiter Endovascular’s chief science officer, added:
“SPIRARE I provides encouraging early evidence that improved procedural stability and control enabled by TFX can translate into meaningful improvements in cardiac function and patient outcomes. Pulmonary embolism is fundamentally a cardiac disease, yet up to one-third of patients remain undertreated and continue to experience persistent symptoms and hemodynamic impairment that may contribute to right heart failure. We believe cardiac function and clinical recovery are the best measures of treatment efficacy in PE, and it is gratifying to see the therapeutic potential of TFX reflected in the SPIRARE I results through this cardiac-centric lens. We are deeply grateful to our pioneering physician partners for their collaboration, and above all, to the patients who placed their trust in us. We look forward to building upon these results in our ongoing SPIRARE II pivotal trial in the U.S. and Europe.”
