Jupiter Endovascular Shares Positive First-in-Human Pulmonary Embolectomy Data

Jupiter Endovascular revealed positive results from the SPIRARE I first-in-human study of its Vertex pulmonary embolectomy system at this week’s Transcatheter Cardiovascular Therapeutics (TCT 2025) conference.

SPIRARE I is the first study to assess Vertex featuring TFX (Transforming Fixation) technology in patients with acute, intermediate-risk pulmonary embolism (PE). The prospective, multicenter European study enrolled ten patients at two sites in Austria and Poland. It was led by professor Irene Lang, MD and professor Grzegorz Kopec, MD, in collaboration with professor Krzysztof Bartus, MD.

Professor Lang said that TFX is an entirely new way to perform endovascular interventions and overcomes the long-standing tradeoff between device access and delivery. He said pulmonary embolism is still and area of unmet need both in the acute phase and long term, where its sequelae can 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,” professor Lang told the press. “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.”

Trial results showed no major adverse events within 48 hours. 80% of procedures were done without re-crossing the heart, and 70% of procedures were completed without using a stiff guidewire. There was 32% improvement in mean pulmonary artery pressure (mPAP), decreasing intraprocedurally from 30.8 mmHg to 20.8 mmHg.

Mean right ventricle/left ventricle (RV/LV) ratio improved by 29%, shrinking from 1.4 to 1.0 at 48 hours after the procedure. There was also 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).

Charles Love, chief science officer of Jupiter Endovascular said SPIRARE I offers 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,” said Love. “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.”

Earlier this month, the company closed an oversubscribed Series B financing that passed its $40 million target. The round was led by Sonder Capital, with participation from Senvest Management, LB Investment, and a new strategic corporate investor.