{"id":63137,"date":"2026-05-20T16:03:08","date_gmt":"2026-05-20T14:03:08","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/jupiter-endovascular-announces-positive-results-from-spirare-ii-pivotal-trial-at-europcr-2026\/"},"modified":"2026-05-20T16:03:08","modified_gmt":"2026-05-20T14:03:08","slug":"jupiter-endovascular-announces-positive-results-from-spirare-ii-pivotal-trial-at-europcr-2026","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/jupiter-endovascular-announces-positive-results-from-spirare-ii-pivotal-trial-at-europcr-2026\/","title":{"rendered":"Jupiter Endovascular Announces Positive Results From SPIRARE II Pivotal Trial at EuroPCR 2026"},"content":{"rendered":"
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\nVertex Pulmonary Embolectomy System demonstrated significant right heart recovery, low adverse event rates, and reproducible performance across high-severity PE patients<\/b><\/p>\n

MENLO PARK, Calif.–(BUSINESS WIRE)–#TFX<\/a>—Jupiter Endovascular, Inc.<\/a> today announced that the SPIRARE II pivotal trial evaluating the use of the company\u2019s Vertex\u2122 Pulmonary Embolectomy System in patients with acute, intermediate-risk pulmonary embolism (PE) met both of its primary endpoints, demonstrating meaningful heart recovery and clinical safety. Late-breaking data from the trial were presented today by Catalin Toma, MD, Director of Interventional Cardiology at the UPMC Heart and Vascular Institute and the trial\u2019s Global Co-Principal Investigator, at EuroPCR 2026 in Paris, France.<\/p>\n

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\n“Pulmonary embolism is fundamentally a cardiovascular disease, where restoration of hemodynamic stability, beyond simple clot removal, is the key determinant of patient recovery,\u201d said Sameh Sayfo, MD, Pulmonary Embolism Response Team Director at Baylor Scott & White The Heart Hospital \u2013 Plano and Global Co-Principal Investigator of SPIRARE II. \u201cHistorically, the ability to achieve both safe right-heart navigation and the procedural stability necessary for controlled PE thrombectomy has represented a significant limitation in consistently normalizing hemodynamics. What makes SPIRARE II particularly compelling is the opportunity to evaluate a system that may enhance not only clot extraction, but also the overall quality, precision, and physiologic impact of the intervention.\u201d<\/p>\n

\nThe Vertex system leverages the company\u2019s patented Transforming Fixation (TFX) platform technology in a novel catheter system designed to navigate flexibly through the right heart and then stabilize on-demand in the pulmonary arteries for precise intervention. The ability for one device to provide both flexible navigation and stable support is intended to address long-standing challenges in PE thrombectomy related to cardiac strain and reliable vessel access within the pulmonary vasculature.<\/p>\n

\nSPIRARE II Results<\/b><\/p>\n

\nSPIRARE II (NCT06576427) is a prospective, single-arm, multicenter pivotal study that enrolled 123 patients across 19 sites in Europe and the U.S. The trial evaluated the safety, right heart functional improvement, and clinical outcomes of PE treatment with the Vertex system.<\/p>\n

\nThe trial met both primary endpoints:<\/p>\n