MENLO PARK, Calif., May 20, 2026
Jupiter Endovascular announced positive topline results from the pivotal SPIRARE II clinical trial evaluating its Vertex™ Pulmonary Embolectomy System in patients with acute intermediate-risk pulmonary embolism (PE). The late-breaking data, presented at the EuroPCR 2026 conference in Paris, demonstrated significant improvements in heart recovery, low adverse event rates, and consistent procedural performance across high-risk PE patients.
Vertex System Demonstrates Strong Heart Recovery in PE Patients
The SPIRARE II trial evaluated the company’s proprietary Transforming Fixation (TFX) platform technology, designed to improve catheter stability and precision during pulmonary embolism thrombectomy procedures. The system is engineered to flexibly navigate the right heart before stabilizing within pulmonary arteries to support controlled clot extraction and hemodynamic recovery.
The prospective, multicenter, single-arm study enrolled 123 patients across 19 sites in Europe and the United States. According to trial investigators, the study successfully met both primary endpoints. Patients treated with the Vertex system achieved a 39% mean reduction in RV/LV ratio at 48 hours, indicating meaningful right-heart recovery. The study also reported a 2.4% major adverse event rate, demonstrating a favorable safety profile.
Invasive hemodynamic assessments further highlighted the therapy’s clinical impact. Researchers observed a 29% reduction in mean pulmonary artery pressure, a 29% decrease in systolic pulmonary artery pressure, and a 26% reduction in total pulmonary vascular resistance following treatment. Investigators emphasized that these improvements extended beyond simple clot removal and reflected broader cardiovascular recovery.
SPIRARE II Shows Efficient and Reproducible Performance
Advertisement
The trial achieved 100% technical success without the use of adjunctive thrombolytic drugs, reinforcing the reproducibility and procedural reliability of the Vertex platform. Treatment efficiency metrics also supported the system’s minimally invasive design. Investigators reported that 83% of procedures did not require re-crossing of the pulmonic valve, while 39% avoided use of a super-stiff guidewire, potentially reducing procedural complexity and cardiac strain.
The average procedure time was approximately 40 minutes, supporting the platform’s operational efficiency in acute care settings. According to the investigators, the patient population enrolled in SPIRARE II represented a particularly severe disease cohort, with 54% presenting with normotensive shock and 93% classified under high-risk PE categories according to updated 2026 ACC/AHA pulmonary embolism guidelines.
Dr. Catalin Toma, Director of Interventional Cardiology at the UPMC Heart and Vascular Institute and Global Co-Principal Investigator of SPIRARE II, stated that the system delivered “consistent, reproducible recovery across all patient classifications,” adding that stable vessel access may have contributed significantly to the physiologic improvements observed during the study.
Jupiter Endovascular Advances Commercialization Strategy
Jupiter Endovascular said the SPIRARE II dataset was designed not only to support future regulatory activities but also to contribute to broader understanding of pulmonary embolism as a complex cardiovascular disease involving right-heart dysfunction and hemodynamic instability.
The company believes its TFX-enabled catheter platform could eventually support additional cardiovascular interventions where stable vascular access remains a major procedural challenge. Beyond pulmonary embolism, Jupiter Endovascular plans to explore future applications across other high-need endovascular treatment areas.
The Vertex Catheter featuring TFX technology is currently FDA 510(k)-cleared for insertion of endovascular devices, while the pulmonary embolectomy indication remains under continued clinical and regulatory development.
Source: Jupiter Endovascular press release
