SPIRARE II evaluates the Vertex pulmonary embolectomy system in patients with acute, intermediate-risk pulmonary embolism (PE). Dr. Vikas Aggarwal, interventional cardiologist at Henry Ford Hospital and the site’s principal investigator, enrolled the final subject.
The prospective study enrolled 123 patients across 23 sites in Europe and the U.S. It follows the SPIRARE I trial, for which Menlo Park, California-based Jupiter reported results last fall. Endpoints for SPIRARE II characterize the procedural and clinical performance of PE treatment with the Vertex system. They span measures of safety, right heart function and clinical improvement from the time of the procedure to 30 days post-procedure.
Learn more about Vertex from an interview with a co-inventor in our free-to-download Min-Vasive Medtech Special Report at Medical Design & Outsourcing.
Vertex incorporates Jupiter’s novel transforming fixation (TFX) technology into an endovascular procedure. It designed the technology to treat acute pulmonary embolism (PE) with control and precision.
The system delivery takes place in a flexible, relaxed state over a guidewire to a target location in the vasculature. Rapidly pressurized with saline, it fixes in a stable position for intervention. Then, it returns to a relaxed state to navigate to another target location or for removal. The system received FDA investigational device exemption in August 2024.
Jupiter won FDA clearance for its Vertex catheter incorporating TFX in September 2025, then announced $40 million in funding weeks later.
“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,” said 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.
“We would like to thank the physicians, researchers, and patients across the U.S., Poland, Austria, and Switzerland whose commitment and participation made this study possible. We look forward to presenting the trial results later this year.”
