Jupiter Endovascular has completed patient enrolment in the SPIRARE II pivotal clinical trial of its Vertex pulmonary embolectomy (PE) system, which uses transforming fixation (TFX) technology for endovascular interventions in patients with acute, intermediate-risk PE.
The final participant was enrolled by Henry Ford Hospital interventional cardiologist and principal investigator Vikas Aggarwal.
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SPIRARE II is a single-arm, multi-centre, pivotal, prospective study and enrolled 123 patients at 23 sites across the US and Europe.
The trial’s endpoints focus on the procedural and clinical performance of the Vertex system for PE treatment, assessing right heart function, safety, and clinical improvements from the procedure through 30 days post-procedure.
The Vertex system employs Jupiter Endovascular’s TFX platform to enable flexible navigation through the right heart before stabilising in the pulmonary arteries for targeted intervention.
This single device approach addresses challenges related to cardiac strain and vessel access during pulmonary embolism thrombectomy by separating flexible navigation from stable support.
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By GlobalDataJupiter Endovascular CEO Carl Bernard said: “Completing enrolment 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. We believe PE thrombectomy must evolve beyond simply debulking thrombus to reliably restoring haemodynamics 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.
“We would like to thank the physicians, researchers, and patients across the US, Austria, Poland and Switzerland, whose commitment and participation made this study possible. We look forward to presenting the trial results later this year.”
In September 2024, Jupiter Endovascular treated the first two patients in the SPIRARE I study, utilising its Vertex PE system.
