Jupiter Endovascular Completes SPIRARE II Trial Enrollment for Vertex Pulmonary Embolectomy System
核心洞察
Jupiter Endovascular (搜索) has completed enrollment of 123 patients across 23 sites in the SPIRARE II pivotal trial evaluating the Vertex Pulmonary Embolectomy System (搜索) for acute, intermediate-risk pulmonary embolism (搜索).
The trial assesses safety, right heart (搜索) functional improvement, and clinical outcomes using Jupiter's proprietary Transforming Fixation (TFX) technology over 30 days post-procedure.
The Vertex system addresses key challenges in pulmonary embolism (搜索) treatment by providing flexible navigation through the right heart (搜索) before stabilizing in pulmonary arteries (搜索) for targeted intervention.
Jupiter Endovascular (搜索) has completed patient enrollment in the SPIRARE II pivotal clinical trial, marking a significant milestone in the development of advanced treatment options for acute, intermediate-risk pulmonary embolism (搜索) (PE). The trial enrolled 123 patients across 23 sites in Europe and the United States to evaluate the safety and efficacy of the company's Vertex Pulmonary Embolectomy System (搜索).
The final subject was enrolled by Dr. Vikas Aggarwal, an interventional cardiologist at Henry Ford Hospital (搜索) and the site's principal investigator. SPIRARE II (NCT06576427) is a prospective, single-arm, multicenter pivotal study designed to characterize the procedural and clinical performance of PE treatment using the Vertex system.
Innovative TFX Technology Platform
The Vertex system incorporates Jupiter's proprietary Transforming Fixation (TFX) technology, which provides on-demand stability and control during transcatheter interventions in the pulmonary vasculature. This technology enables flexible navigation through the right heart (搜索) before stabilizing in the pulmonary arteries (搜索) for targeted intervention, addressing key challenges related to cardiac strain and vessel access during pulmonary embolism (搜索) thrombectomy.
"The Vertex system employs Jupiter Endovascular (搜索)'s TFX platform to enable flexible navigation through the right heart (搜索) before stabilising in the pulmonary arteries (搜索) for targeted intervention," according to the trial description. This single device approach separates flexible navigation from stable support, potentially improving procedural outcomes.
Clinical Trial Design and Endpoints
The trial endpoints focus on measuring safety, right heart (搜索) function, and clinical improvement from the time of the procedure through 30 days post-procedure. This comprehensive approach reflects a shift in how clinicians approach pulmonary embolism (搜索) treatment, moving beyond simple clot removal to address the underlying cardiac impact of the condition.
"Pulmonary embolism (搜索) is fundamentally a cardiac disease that places acute strain on the right heart (搜索)," said Dr. Catalin Toma, Director of Interventional Cardiology at the UPMC Heart and Vascular Institute (搜索) and the trial's Global Co-Principal Investigator. "Technologies that enable safe, reliable access to the pulmonary arteries (搜索) while allowing operators to focus on normalizing cardiac function have the potential to positively impact how we treat these patients."
Paradigm Shift in PE Treatment
The SPIRARE II trial represents a fundamental change in how physicians approach pulmonary embolism (搜索) treatment. Dr. Sameh Sayfo, Pulmonary Embolism Response Team Director at Baylor Scott & White The Heart Hospital (搜索) – Plano and the trial's Global Co-Principal Investigator, emphasized this evolution: "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."
Dr. Sayfo further noted that "this trial isn't just measuring clot removal; it is redefining our understanding of the physiologic recovery made possible through TFX-enabled thrombectomy."
Company Perspective and Future Outlook
Jupiter Endovascular (搜索) CEO Carl Bernard highlighted the significance of completing enrollment: "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 (搜索). We believe PE thrombectomy must evolve beyond simply debulking thrombus to reliably restoring haemodynamics and supporting cardiac recovery."
Bernard emphasized that "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."
The company expressed gratitude to physicians, researchers, and patients across the United States, Austria, Poland, and Switzerland for their participation in making the study possible. Trial results are expected to be presented later this year.
Clinical Development Progress
This milestone builds on Jupiter Endovascular (搜索)'s ongoing clinical development program. In September 2024, the company treated the first two patients in the SPIRARE I study, also utilizing the Vertex PE system, demonstrating continued progress in advancing this technology through clinical evaluation.