Jupiter Endovascular, Inc., a medical technology company developing next-generation endovascular interventions based on its proprietary Transforming Fixation (TFX) platform, announced positive results from the SPIRARE I first-in-human (FIH) study. Data were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference by Professor Irene Lang, MD, Principal Investigator and Professor of Vascular Biology at the Medical University of Vienna.
About the SPIRARE I Study
SPIRARE I (NCT06571760) is the first clinical trial to evaluate the safety and performance of Jupiter Endovascular’s Vertex Pulmonary Embolectomy System featuring TFX technology in patients with acute, intermediate-risk pulmonary embolism (PE).
The prospective, multicenter European study enrolled 10 patients across two sites in Austria and Poland, led by Professor Irene Lang, MD, and Professor Grzegorz Kopec, MD, in collaboration with Professor Krzysztof Bartus, MD.
Novel Technology for Endovascular Interventions
“TFX represents an entirely new way to perform endovascular interventions, overcoming the long-standing tradeoff between device access and delivery,” said Professor Lang.
She added, “Pulmonary embolism remains an area of major unmet need. The exceptional stability and control provided by TFX have the potential to substantially unload the right heart and normalize hemodynamics. In this study, most procedures were completed without re-crossing the heart or using a stiff guidewire, and results demonstrated excellent safety with marked improvements in right heart function and clinical recovery.”
Promising Early Outcomes
According to the company, SPIRARE I results showed encouraging signs of improved cardiac function and patient recovery, with a favorable safety profile.
“SPIRARE I provides early evidence that enhanced procedural stability and control enabled by TFX can lead to meaningful improvements in cardiac outcomes,” said Charles Love, Chief Science Officer, Jupiter Endovascular.
“Pulmonary embolism is fundamentally a cardiac disease, yet many patients remain undertreated and experience lasting hemodynamic impairment,” Love added. “It is gratifying to see the therapeutic potential of TFX reflected in the SPIRARE I results through a cardiac-centric lens. We thank our physician partners and, above all, the patients who placed their trust in us.”
Next Steps: SPIRARE II Pivotal Trial
Building on the success of SPIRARE I, Jupiter Endovascular is conducting the SPIRARE II (NCT06576427) pivotal trial — a prospective, single-arm, multicenter study enrolling up to 145 patients across 25 sites in the U.S. and Europe.
The trial aims to further assess the safety, procedural efficacy, and clinical benefits of TFX-enabled pulmonary embolectomy in patients with acute, intermediate-risk PE.
About Jupiter Endovascular
Jupiter Endovascular, Inc. is a medical technology company pioneering a new class of endovascular interventions powered by its proprietary Transforming Fixation (TFX) platform. The TFX-enabled approach is designed to deliver unmatched procedural stability, control, and anatomical protection in catheter-based cardiovascular therapies.
