SPIRARE II Pivotal Trial of Jupiter’s Vertex Pulmonary Embolectomy System Completes Enrollment

February 5, 2026—Jupiter Endovascular, Inc. announced completion of patient enrollment in the SPIRARE II pivotal clinical trial evaluating the company’s Vertex pulmonary embolectomy system in patients with acute, intermediate-risk pulmonary embolism (PE). The final patient was enrolled by interventional cardiologist Vikas Aggarwal, MD, at Henry Ford Hospital in Detroit, Michigan.

According to Jupiter Endovascular, SPIRARE II is a prospective, single-arm, multicenter pivotal study. Investigators enrolled 123 patients across 23 sites in Europe and the United States.

The trial endpoints characterize the procedural and clinical performance of PE treatment with the Vertex system across measures of safety, right heart function, and clinical improvement from the time of the procedure to 30 days postprocedure, stated the company.

The Vertex system incorporates Jupiter’s Transforming Fixation (TFX) technology to provide stability and control during transcatheter interventions in the pulmonary vasculature. Currently, the Vertex catheter with TFX technology is 510(k)-cleared by the FDA for the insertion of endovascular devices, advised the company.

The SPIRARE II trial’s Global Coprincipal Investigators are Catalin Toma, MD, and Sameh Sayfo, MD.

“Completion of enrollment in SPIRARE II represents a major milestone for both the SPIRARE clinical program and the broader PE field,” commented Dr. Toma in the Jupiter Endovascular press release. “Pulmonary embolism is fundamentally a cardiac disease that places acute strain on the right heart. Technologies that enable safe, reliable access to the pulmonary arteries while allowing operators to focus on normalizing cardiac function have the potential to positively impact how we treat these patients.”

Dr. Sayfo added, “The high level of investigator engagement in SPIRARE II underscores a critical shift in how we approach pulmonary embolism, moving toward total procedural control and intentional access to drive superior clinical outcomes. This trial isn’t just measuring clot removal; it is redefining our understanding of the physiologic recovery made possible through TFX-enabled thrombectomy. We are deeply indebted to the patients whose participation is helping us set a new global standard for PE care.”