Jupiter Endovascular Completes Enrollment in SPIRARE II Pulmonary Embolectomy Trial

The pivotal study evaluates the company's Vertex system for treating acute, intermediate-risk pulmonary embolism.

Published on Feb. 9, 2026

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Jupiter Endovascular, Inc. has announced the completion of patient enrollment in the SPIRARE II pivotal clinical trial evaluating the company's Vertex pulmonary embolectomy system. The trial enrolled 123 patients across 23 sites in Europe and the United States to assess the procedural and clinical performance of the Vertex system in treating acute, intermediate-risk pulmonary embolism.

Why it matters

Pulmonary embolism is a serious cardiac condition that requires effective treatment to normalize right heart function and improve patient outcomes. The Vertex system's Transforming Fixation (TFX) technology aims to provide stable and controlled access to the pulmonary vasculature, which could lead to superior clinical results compared to existing thrombectomy approaches.

The details

The SPIRARE II trial is a prospective, single-arm, multicenter pivotal study that will evaluate the safety, right heart function, and clinical improvement of patients treated with the Vertex system from the time of the procedure to 30 days postprocedure. The Vertex system is currently 510(k)-cleared by the FDA for the insertion of endovascular devices.

  • The final patient was enrolled by interventional cardiologist Vikas Aggarwal, MD, at Henry Ford Hospital in Detroit, Michigan on February 5, 2026.
  • The SPIRARE II trial's Global Coprincipal Investigators are Catalin Toma, MD, and Sameh Sayfo, MD.

The players

Jupiter Endovascular, Inc.

A medical device company developing technologies for the treatment of pulmonary embolism and other cardiovascular conditions.

Vertex pulmonary embolectomy system

Jupiter Endovascular's device that incorporates the company's Transforming Fixation (TFX) technology to provide stable and controlled access to the pulmonary vasculature during thrombectomy procedures.

Catalin Toma, MD

Global Coprincipal Investigator of the SPIRARE II trial.

Sameh Sayfo, MD

Global Coprincipal Investigator of the SPIRARE II trial.

Vikas Aggarwal, MD

Interventional cardiologist at Henry Ford Hospital in Detroit, Michigan who enrolled the final patient in the SPIRARE II trial.

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What they’re saying

“Completion of enrollment in SPIRARE II represents a major milestone for both the SPIRARE clinical program and the broader PE field. 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.”

— Catalin Toma, MD, Global Coprincipal Investigator (Jupiter Endovascular press release)

“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.”

— Sameh Sayfo, MD, Global Coprincipal Investigator (Jupiter Endovascular press release)

What’s next

The SPIRARE II trial will now proceed to evaluate the procedural and clinical performance of the Vertex pulmonary embolectomy system, with results expected in the coming months.

The takeaway

The completion of enrollment in the SPIRARE II trial represents a significant milestone in the development of new technologies aimed at improving the treatment of pulmonary embolism, a serious cardiac condition that requires effective interventions to restore right heart function and improve patient outcomes.