SPIRARE II evaluates the Vertex system in patients with acute, intermediate-risk pulmonary embolism (PE). Menlo Park, California-based Jupiter completed enrollment in the trial in February. The company said today that the study met both primary endpoints, demonstrating meaningful heart recovery and clinical safety.
Dr. Catalin Toma, director of interventional cardiology at the UPMC Heart and Vascular Institute and global co-principal investigator for SPIRARE II, presented findings at EuroPCR 2026 in Paris.
Vertex incorporates Jupiter’s novel transforming fixation (TFX) technology into an endovascular procedure. It designed the technology to treat acute pulmonary embolism (PE) with control and precision.
The system delivery takes place in a flexible, relaxed state over a guidewire to a target location in the vasculature. Rapidly pressurized with saline, it fixes in a stable position for intervention. Then, it returns to a relaxed state to navigate to another target location or for removal. The system received FDA investigational device exemption in August 2024.
Jupiter won FDA clearance for its Vertex catheter incorporating TFX in September 2025, then announced $40 million in funding weeks later.
A look at the findings presented at EuroPCR 2026
SPIRARE II enrolled 123 patients across 19 sites in the U.S. and Europe. It evaluated safety, right heart functional improvement and clinical outcomes in PE treatment with Vertex.
The study met both primary endpoints with a 0.39 mean reduction in RV/LV ratio at 48 hours and 2.4% major adverse event rate (3/123).
TFX-enabled thrombectomy achieved meaningful afterload reduction and right heart recovery beyond clot extraction, Jupiter said. Investigators saw a 29% reduction in mean pulmonary artery pressure (mPAP), 29% reduction in systolic pulmonary artery pressure (sPAP) and a 26% reduction in total pulmonary vascular resistance (TPVR).
SPIRARE II achieved 100% technical success with zero use of adjunctive thrombolytics, the company said. Treatment characteristics demonstrated an efficient and minimally invasive procedure.
Investigators said that 83% of cases did not require re-crossing of the pulmonic valve, 39% of cases did not require use of a super-stiff guidewire and they saw a 40.2-minute mean procedure time.
Commentary from Jupiter Endovascular officials and study investigators
Carl J. St. Bernard, CEO of Jupiter Endovascular, said:
“SPIRARE II was designed not only to support regulatory clearance, but also to generate a robust clinical dataset that includes paired invasive hemodynamics and detailed patient-level data across a population of elevated severity. We believe these findings will contribute to a growing understanding of pulmonary embolism as a complex cardiovascular disease centered on right heart dysfunction and hemodynamic compromise, not defined by clot burden alone. We are deeply grateful to the patients, investigators, and clinical teams who participated in SPIRARE II and helped advance the field toward a more sophisticated approach to PE care. As we move toward commercialization, we see a significant opportunity to apply our TFX platform technology across other complex cardiovascular anatomies where stable access and controlled intervention remain major unmet needs.”
Dr. Toma added:
“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 ACC/AHA PE guidelines. 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. 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.”
Dr. Sameh Sayfo, pulmonary embolism response team director at Baylor Scott & White The Heart Hospital – Plano and co-principal investigator, said:
“Pulmonary embolism is fundamentally a cardiovascular disease, where restoration of hemodynamic stability, beyond simple clot removal, is the key determinant of patient recovery. Historically, the ability to achieve both safe right-heart navigation and the procedural stability necessary for controlled PE thrombectomy has represented a significant limitation in consistently normalizing hemodynamics. What makes SPIRARE II particularly compelling is the opportunity to evaluate a system that may enhance not only clot extraction, but also the overall quality, precision, and physiologic impact of the intervention.”
