Jupiter Endovascular Announces Publication of SPIRARE II Pivotal Trial Results Showing Vertex Thrombectomy System Normalized Hemodynamics in 50% of Pulmonary Embolism Patients

Peer-reviewed Data Published in EuroIntervention Also Demonstrated Vertex System Achieved Rapid Afterload Relief – or Reduction in Heart Strain – and Symptom Improvement

MENLO PARK, Calif., October 19, 2026--Jupiter Endovascular, Inc. today announced publication of full results from its SPIRARE II pivotal trial evaluating the Vertex™ Thrombectomy System in patients with acute, intermediate-risk pulmonary embolism (PE), in the latest issue of EuroIntervention. The trial met all primary and secondary endpoints at 48 hours, with sustained symptom improvement through 30 days, in a patient population of elevated clinical severity. The publication builds on topline data first presented at EuroPCR 2026, adding complete clinical methodology, patient severity breakdowns, and invasive physiologic outcomes.

The Vertex system leverages the company's proprietary Transforming Fixation (TFX) platform technology, a single catheter designed to navigate flexibly through the right heart and stabilize on-demand in the pulmonary arteries for precise, controlled intervention. This ability to combine flexible navigation and stable support in one catheter addresses long-standing challenges in PE thrombectomy related to cardiac strain and reliable vessel access.

The study evaluated a patient population where 85% of patients were classified as intermediate-high risk by ESC 2019 criteria. In a post-hoc analysis applying the 2026 AHA/ACC multi-society PE guidelines, 54% met the criteria for normotensive cardiogenic shock, a state in which normal blood pressure can mask underlying hemodynamic compromise and delay recognition, potentially increasing procedural risk.

SPIRARE II Results

Primary Endpoints:

• 0.39 mean reduction in RV/LV ratio at 48 hours (95% CI: 0.33, 0.45; p<0.0001)

• 2.4% major adverse event (MAE) rate (3/123; p<0.0001)

TFX-enabled thrombectomy with the Vertex system delivered meaningful afterload reduction, rapid right heart recovery, and durable symptom relief:

• Direct Hemodynamic Normalization: 29% reduction in mean pulmonary artery pressure (mPAP, −8.5 ± 6.3 mmHg), the directly measured invasive endpoint, with 50% of all patients reaching complete mPAP normalization (≤20 mmHg).

• Pulmonary Vascular Relief: 29% reduction in systolic pulmonary artery pressure (sPAP, −14.2 ± 10.5 mmHg) and a 26% reduction in total pulmonary vascular resistance (TPVR, –1.7 ± 2.3 Wood units).

• Sustained Symptom Improvement: 85% relative reduction in severe or very severe dyspnea (modified Medical Research Council grade), dropping from 58% of patients at baseline to 8% at 48 hours and 3% at 30 days.