Jupiter Endovascular completes enrollment in Vertex pulmonary embolectomy trial

The SPIRARE II study evaluates the Vertex system in patients with acute, intermediate-risk pulmonary embolism.

Published on Feb. 4, 2026

Jupiter Endovascular announced that it has completed patient enrollment in the SPIRARE II pivotal clinical trial evaluating its Vertex system for treating acute, intermediate-risk pulmonary embolism (PE). The prospective study enrolled 123 patients across 23 sites in Europe and the U.S. and will characterize the procedural and clinical performance of PE treatment with the Vertex system.

Why it matters

The Vertex system incorporates Jupiter's novel transforming fixation (TFX) technology, which is designed to treat acute pulmonary embolism with control and precision. Completing enrollment in the SPIRARE II trial is a significant milestone that will generate data to support the clinical promise of TFX technology in treating complex cardiovascular diseases.

The details

The SPIRARE II trial follows the SPIRARE I trial, for which Jupiter reported results last fall. Endpoints for SPIRARE II span measures of safety, right heart function, and clinical improvement from the time of the procedure to 30 days post-procedure. The Vertex system delivery takes place in a flexible, relaxed state over a guidewire to a target location in the vasculature. It then rapidly pressurizes with saline to fix in a stable position for intervention, before returning to a relaxed state to navigate to another target location or for removal.

  • Jupiter Endovascular received FDA investigational device exemption for the Vertex system in August 2024.
  • Jupiter won FDA clearance for its Vertex catheter incorporating TFX in September 2025.

The players

Jupiter Endovascular

A medical device company that developed the Vertex pulmonary embolectomy system.

Vertex

Jupiter Endovascular's pulmonary embolectomy system that incorporates the company's novel transforming fixation (TFX) technology.

Dr. Vikas Aggarwal

The interventional cardiologist at Henry Ford Hospital and the principal investigator for the SPIRARE II trial.

Carl J. St. Bernard

The CEO of Jupiter Endovascular.

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What they’re saying

“Completing enrollment in SPIRARE II is a testament to the dedication of our investigators and the strength of the clinical hypothesis underlying the use of TFX in treating pulmonary embolism.”

— Carl J. St. Bernard, CEO of Jupiter Endovascular

“We believe PE thrombectomy must evolve beyond simply debulking thrombus to reliably restoring hemodynamics and supporting cardiac recovery. SPIRARE II is designed to generate data to support that shift and to demonstrate the clinical promise of TFX technology in treating diseases residing in complex cardiovascular anatomies.”

— Carl J. St. Bernard, CEO of Jupiter Endovascular

What’s next

Jupiter Endovascular plans to present the SPIRARE II trial results later this year.

The takeaway

The completion of enrollment in the SPIRARE II trial is a significant milestone for Jupiter Endovascular's Vertex system, which utilizes novel TFX technology to treat acute pulmonary embolism with precision. The data from this trial will help demonstrate the clinical promise of this approach in addressing complex cardiovascular diseases.