Jupiter Endovascular, Inc. announced new analyses from its SPIRARE II pivotal trial showing that restoring normal pulmonary artery pressure with the Vertex™ Thrombectomy System tracked with right heart recovery at 48 hours. The analysis also demonstrated that reaching the lower lobes of the lungs with the system was associated with greater hemodynamic restoration. The data was presented at the Transcatheter Cardiovascular Therapeutics (TCT 2026) conference in San Diego by Sripal Bangalore, MD, MHA, Professor of Medicine at NYU Grossman School of Medicine.
In pulmonary embolism (PE), right ventricular (RV) failure, rather than the clot itself, is the primary driver of mortality. While most PE trials have relied on measuring RV/LV ratio – or heart size – solely with CT imaging, the 123-patient SPIRARE II trial also measured the physiology directly. Invasive right heart catheterization was used to record pressures in the heart and lungs before and immediately after treatment in all 123 patients, along with independent core laboratory echocardiography which recorded RV function at baseline and 48 hours.
Post-Hoc Analysis Findings from SPIRARE II
In a new post-hoc analysis, 93% of patients treated with the Vertex system showed a reduction in mean pulmonary artery pressure, and half ended the procedure with pressures in the normal range (mean ≤20 mmHg). At 48 hours, patients who reached normal pressure were more likely to have RV recovery, as defined by RV-PA coupling, which is an established marker of right heart function. The findings add to previously reported results in which the Vertex system reduced mean pulmonary artery pressure by an average of 8.5 mmHg (29%), immediately relieving strain on the right ventricle, with consistent results across all 19 sites.
This analysis also showed that accessing a greater number of vessels during a procedure, including the lower lung lobes, resulted in a higher likelihood of pressure normalization. While exploratory, these post hoc findings suggest the lower lobes may be an important target for restoring normal hemodynamics. “What stands out is that an intra-procedural normalization of mean pulmonary artery pressure is one of the indicators of how well the right ventricle functions two days later,” said Dr. Bangalore. “It also raises an important question for our field about how complete we should be with clot removal, including targeting the lower lobes, and how that shapes a patient’s recovery.”
Reaching the lower lobes involves navigating a dilated, struggling right heart and holding position deep in the pulmonary arteries. Built on the company’s proprietary Transforming Fixation (TFX) technology, the Vertex catheter used in the Vertex system is designed to navigate flexibly through the right heart and stabilize on demand in the pulmonary arteries for controlled intervention, allowing physicians to redirect the catheter from lobe to lobe without re-crossing the pulmonic valve. By reducing the need to continually manage catheter position and stability, TFX allows physicians to focus more on delivering therapy than on maintaining access. In SPIRARE II, 83% of cases did not require re-crossing of the pulmonic valve, and no patient received adjunctive thrombolytics.
“SPIRARE II was built around the outcome that matters most to patients with PE: recovery of the right heart,” said Catalin Toma, MD, Chief Medical Officer of Jupiter Endovascular and Global Co-Principal Investigator of SPIRARE II. “Measuring physiology directly in every patient, rather than relying on imaging alone, gives us a clearer view of that recovery. TFX was designed to give physicians stable, controlled access to hard-to-reach anatomy, and these findings support our belief that this is where meaningful hemodynamic gains are made.”
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 met its primary effectiveness (RV/LV reduction at 48 hours) and safety (major adverse events at 48 hours) endpoints. Imaging endpoints were assessed by an independent, blinded core laboratory and all adverse events were adjudicated by an independent clinical events committee. Full results were recently published in EuroIntervention (Sayfo S, et al. 2026;22:e1115–e1126).
About Jupiter Endovascular, TFX Technology, and the Vertex™ Thrombectomy System
Jupiter Endovascular Inc. is a Menlo Park, California-based medical technology company developing a new class of endovascular interventions using its proprietary Transforming Fixation (TFX) platform technology. The company’s Vertex Thrombectomy System leverages TFX technology to navigate flexibly through the right heart and transform on demand into a stabilized state in the pulmonary arteries for precise, controlled intervention. Its 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. For more information, visit jupiterendo.com.
Forward-looking statements contained in this press release are based on estimates and assumptions of Jupiter Endovascular management and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made. We do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied based on a number of factors, including but not limited to, unexpected clinical trial timing and outcomes, results of expanded clinical experience, and unanticipated impacts of regulatory decisions.
Rx Only. The Vertex Thrombectomy System is indicated for use in the pulmonary arteries for: the non-surgical removal of emboli and thrombi, and the injection, infusion, and/or aspiration of contrast media and other fluids. The Vertex Thrombectomy System is intended for the treatment of pulmonary embolism. Before use, refer to the Instructions for Use for complete indications, contraindications, warnings, precautions, potential adverse events, and instructions. Please visit https://jupiterendo.com/safety/ for important safety information.
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