Jupiter Endovascular has announced the successful treatment of its first two patients in the SPIRARE I clinical study, which is investigating the Vertex Pulmonary Embolectomy System.
The procedure utilised the company’s Endoportal Control platform technology. The Vertex system has been developed to treat acute pulmonary embolism (PE) through a minimally invasive endovascular procedure, aiming to offer enhanced control and precision during treatment.
Jupiter Endovascular, a US-based medical technology company, specialises in the development of novel endovascular procedures using the Endoportal Control platform. The first successful treatments took place at St. John Paul II Hospital, Krakow, Poland, a specialist cardiothoracic centre associated with Jagiellonian University.
The SPIRARE I study is designed as a prospective, single-arm, multicenter trial. It enrols patients with acute, intermediate-risk pulmonary embolism treated with the Vertex Pulmonary Embolectomy System.
Alongside St. John Paul II Hospital, the Medical University of Vienna is planned as a secondary trial site, with Professor Irene Lang serving as the principal investigator for that location.
The study aims to assess the procedural and clinical benefits of the Endoportal Control platform integrated into the Vertex system. It will evaluate measures such as safety, right heart function, and overall clinical improvement from the procedure date to 30 days post-treatment.
The Endoportal Control platform is specifically designed to provide greater stability in various catheter-based interventions, allowing interventionalists to access anatomical sites that are challenging to reach with traditional endovascular techniques.
The device is deployed over a guidewire in a relaxed state, pressurised with saline to secure its position for therapeutic delivery, and then relaxed again to navigate to other target sites or for removal.
Jupiter Endovascular CEO Carl Bernard said: “We are delighted with the performance of our technology in these first two cases, demonstrating safe access and the ability to bring a high degree of precision and control to the successful treatment of these patients with intermediate-risk pulmonary embolism.
“As the first step in our SPIRARE clinical programme, we look forward to validating these positive results more broadly in this study and in the upcoming SPIRARE II pivotal trial, as well as expanding the potential benefits of our Endoportal Control platform technology to additional clinical areas where we intend to improve the lives and well-being of many patients.”
Recently, Jupiter Endovascular secured the US Food and Drug Administration (FDA) approval for the SPIRARE II US study of the Vertex Pulmonary Embolectomy System. The investigational device exemption (IDE) study will evaluate the system’s use in an endovascular procedure to treat acute pulmonary embolism.
