The US Food and Drug Administration (FDA) has granted approval for Jupiter Endovascular’s investigational device exemption (IDE) application filed for the SPIRARE II US pivotal study of its Vertex pulmonary embolectomy system to treat acute pulmonary embolism (PE).
This system utilises the company's Endoportal Control technology to enhance precision in catheter-based interventions.
The prospective, single-arm SPIRARE II trial is designed to evaluate the Vertex system in treating patients with acute PE.
It will enrol up to 145 patients across approximately 25 US sites, aiming to demonstrate the procedural and clinical benefits of the new technology.
As part of the study, the company will assess the Vertex system's impact on right heart function and patient outcomes up to 30 days post-procedure.
The Endoportal Control platform is a significant innovation in endovascular procedures, allowing for more stable and precise treatment delivery.
The device is navigated to the target area flexibly before being pressurised to remain fixed during the procedure and finally relaxed for repositioning or removal.
This pivotal study is part of Jupiter Endovascular's broader SPIRARE clinical programme, including the European-based SPIRARE I trial.
Jupiter Endovascular CEO Carl St Bernard said: “We are excited about FDA approval of the first pivotal study of a system leveraging our Endoportal Control platform technology. In the more than 25 animal studies conducted to date with the technology, it has demonstrated safe and easy navigation through the heart and vasculature and effective delivery of test interventions.
“Endoportal Control has the potential to meaningfully improve many endovascular procedures while enabling entirely new therapies. Our Vertex system for pulmonary embolectomy is the first of what we intend to be a portfolio of our own interventional procedure systems incorporating Endoportal Control to treat a variety of cardiovascular conditions that affect millions of patients worldwide.”
Earlier this month, Jupiter Endovascular emerged from stealth with $21m in new financing as it looks to forge its new type of endovascular procedure.
