Jupiter’s Vertex PE System Evaluated in SPIRARE II Pivotal Trial

May 26, 2026—Jupiter Endovascular announced results from the SPIRARE II pivotal trial of the company’s Vertex pulmonary embolectomy system in the treatment of patients with acute, intermediate-risk pulmonary embolism (PE).

Jupiter Endovascular stated that the prospective, single-arm, multicenter trial evaluated the safety, right heart functional improvement, and clinical outcomes associated with the Vertex system. The study enrolled 123 patients across 19 sites in Europe and the United States.

The Global Coprincipal Investigators for SPIRARE II are Catalin Toma, MD, and Sameh Sayfo, MD.

Dr. Toma presented the late-breaking SPIRARE II data at EuroPCR 2026 in Paris, France.

According to the company, the SPIRARE II trial met both primary endpoints with the following findings:

• 39% mean reduction in right ventricular/left ventricular (RV/LV) ratio at 48 hours (95% CI, 0.33-0.45)
• 2.4% major adverse event rate (3/123; P < .0001)

Additionally, the investigators reported paired invasive hemodynamic improvements, including a 29% reduction in mean pulmonary artery pressure; a 29% reduction in systolic pulmonary artery pressure; and a 26% reduction in total pulmonary vascular resistance.

Procedurally, there was 100% technical success with no adjunctive thrombolytic use; further, there was no pulmonic valve recrossing in 83% of cases, no requirement for a superstiff guidewire in 39% of procedures, and a mean procedure time of 40.2 ± 16.4 minutes.

The Vertex PE system leverages Jupiter Endovascular’s transforming fixation (TFX) platform technology to navigate flexibly through the right heart and transform into a stabilized state in the pulmonary arteries, noted the press release.

“The SPIRARE II results are especially impressive, recognizing the hemodynamic 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/American Heart Association PE guidelines,” Dr. Toma stated in the press release. “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.”

Dr. Toma continued, “Future post-hoc analyses will help us better understand the relationship between vessel access and the depth of physiologic recovery we observed. We believe these findings will meaningfully inform the approach to PE intervention moving forward.”