Jupiter SPIRARE I FIH Trial of Vertex Pulmonary Embolectomy System Commences

September 19, 2024—Jupiter Endovascular, Inc. announced that the first two patients were treated in the SPIRARE I trial of the Vertex pulmonary embolectomy system using the company’s Endoportal Control platform technology.

SPIRARE I is a prospective, single-arm, multicenter study enrolling patients with acute, intermediate-risk pulmonary embolism (PE) treated with the Vertex system.

According to the company, trial endpoints will characterize the procedural and clinical benefits of pulmonary embolectomy with Endoportal Control using the Vertex system across measures of safety, right heart function, and clinical improvement from the time of the procedure to 30 days postprocedure.

The successful first two cases were performed by study investigators Professor Grzegorz Kopec, MD; Jakub Stepniewski, MD; and Professor Krzysztof Bartus, MD, at St. John Paul II Hospital, a cardiothoracic specialist center affiliated with the Jagiellonian University in Kraków, Poland.

At St. John Paul II Hospital, Prof. Kopec is Head of the diagnosis and treatment of pulmonary circulatory diseases team; Dr. Stepniewski is the Pulmonary Embolism Response Team Coordinator; and Prof. Bartus is Professor of Medicine.

The Medical University of Vienna in Austria is the planned second site, and Professor Irene Lang, MD, will serve as Principal Investigator.

“In these first cases, the Vertex system was successful in safely navigating through the right heart and into the pulmonary vasculature, facilitating an efficient and effective pulmonary embolectomy with no safety issues,” commented Prof. Kopec in the company’s press release. “The patients’ clinical condition and hemodynamics improved on the table during the procedure, and postoperative imaging showed noticeable improvements in right heart function”.

Dr. Stepniewski added, “Controlling interventional devices within the pulmonary arterial tree when treating patients with intermediate-risk and high-risk PE can be challenging with today’s commercially available technology. The endoportal technology enabled the large-bore Vertex system to remain stable in tachypneic patients, allowing us to quickly access and revascularize multiple areas of the pulmonary vasculature in a controlled manner when facing a high degree of cardiorespiratory movement.”

Finally, Prof. Bartus stated, “I was pleasantly surprised that the endoportal technology provided a level of control similar to what I experience in an open surgical embolectomy, with the added ability to directly access a much wider range of vessels. My team and I are very excited about studying a new technology with the potential to give us greater stability and control when treating PE, which may have a positive impact on patient outcomes.”