Jupiter Endovascular has shared positive pivotal trial results for its Vertex pulmonary embolectomy system in treating pulmonary embolism (PE).
The 123-patient SPIRARE II trial (NCT06576427) evaluated the safety, right heart functional improvement, and clinical outcomes of PE treatment with the Vertex system.
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Meeting both its primary endpoints, Vertex achieved a 0.39 mean reduction in the right ventricle to left ventricle (RV/LV) ratio at 48 hours, demonstrating significant haemodynamic recovery and reversal of right heart strain, with a major adverse event (MAE) rate of 2.4%.
RV/LV ratio serves as a key diagnostic marker to assess right heart strain, evaluate PE severity, and guide clinical treatment.
The late-breaking trial data was shared at the EuroPCR 2026 congress, taking place from 19-22 May in Paris, France.
Catalin Toma, director of interventional cardiology at the UPMC Heart and Vascular Institute and co-principal investigator of SPIRARE II trial, said: “The SPIRARE II results are especially impressive, recognising the haemodynamic severity of the patient population – 54% presented with normotensive shock and 93% were classified in C3 or D2 risk categories under the 2026 American College of Cardiology and American Heart Association (ACC/AHA) PE guidelines.”
Jupiter’s Vertex uses its proprietary transforming fixation (TFX) platform technology, designed to simplify navigation through the right heart into the pulmonary arteries for PE intervention. According to Jupiter, TFX technology’s capability to decouple flexible navigation from stable support addresses long-standing challenges in PE thrombectomy in relation to cardiac strain, guidewire reliance, and reliable vessel access.
Toma continued: “TFX-enabled thrombectomy delivered consistent, reproducible recovery across all patient classifications, which we believe was achieved by having stable, controlled access to target vessel obstructions.”
Other trial data indicated that TFX thrombectomy achieved meaningful afterload reduction and right heart recovery beyond clot extraction. This was demonstrated by improvements in pulmonary artery pressures and vascular resistance.
Jupiter’s CEO, Carl J. St. Bernard, highlighted that the SPIRARE II trial was not only designed to support regulatory, but also to generate a “robust clinical dataset that includes paired invasive haemodynamics and detailed patient-level data” across a population of elevated severity.
“We believe these findings will contribute to a growing understanding of PE as a complex cardiovascular disease centred on right heart dysfunction and haemodynamic compromise, not defined by clot burden alone,” Bernard said.
Boston Scientific was among the other companies that presented trial data at EuroPCR 2026. The company revealed data from the FRACTURE trial (NCT06181240), showcasing the efficacy of its SEISMIQ 4CE Coronary intravascular lithotripsy (IVL) catheter for treating calcified coronary artery disease (CAD).
