Trial Evaluates Safety, Right Heart Functional Improvement, and Clinical Outcomes of Vertex Pulmonary Embolectomy System with Transforming Fixation (TFX)
MENLO PARK, Calif.–(BUSINESS WIRE)–#FDA–Jupiter Endovascular, Inc., a medical technology company developing a new class of endovascular interventions using its proprietary Transforming Fixation (TFX) technology, today announced completion of patient enrollment in the SPIRARE II pivotal clinical trial evaluating the Vertex™ Pulmonary Embolectomy System in patients with acute, intermediate-risk pulmonary embolism (PE). The final subject was enrolled by Vikas Aggarwal, MD, Interventional Cardiologist at Henry Ford Hospital and the site’s Principal Investigator.
SPIRARE II (NCT06576427) is a prospective, single-arm, multicenter pivotal study that enrolled 123 patients across 23 sites in Europe and the U.S. 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 post-procedure. The Vertex system incorporates Jupiter’s TFX technology to provide on-demand stability and control during transcatheter interventions in the pulmonary vasculature.
“Completion of enrollment in SPIRARE II represents a major milestone for both the SPIRARE clinical program and the broader PE field,” said Catalin Toma, MD, Director of Interventional Cardiology at the UPMC Heart and Vascular Institute and the trial’s Global Co-Principal Investigator. “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.”
“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,” said Sameh Sayfo, MD, Pulmonary Embolism Response Team Director at Baylor Scott & White The Heart Hospital – Plano and the trial’s Global Co-Principal Investigator. “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.”
The Vertex Pulmonary Embolectomy System leverages the company’s TFX platform technology to navigate flexibly through the right heart and transform into a stabilized state in the pulmonary arteries for precise intervention. The unique capability for a single TFX-enabled device to decouple the characteristics of flexible navigation from stable support is intended to address long-standing challenges in PE thrombectomy related to cardiac strain and reliable vessel access within the pulmonary vasculature.
“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.”
About Jupiter Endovascular
Jupiter Endovascular is a medical technology company developing a new class of endovascular interventions powered by its proprietary Transforming Fixation (TFX) platform technology. A TFX-enabled procedure is designed to bring unmatched stability, control, and anatomical protection to catheter-based therapies. By allowing interventionalists to navigate flexibly through the vasculature and then stabilize with precise control at the treatment site while remaining conformed to the anatomy, Jupiter aims to expand the boundaries of endovascular medicine. The company’s initial focus is pulmonary embolism, with plans to expand into additional high-need cardiovascular applications. The Vertex Catheter featuring TFX technology is 510(k)-cleared by the FDA for the insertion of endovascular devices. To learn more, visit www.jupiterendo.com.
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