Jupiter Endovascular, Inc., a medical tech innovator specializing in advanced endovascular procedures through Endoportal Control™, has received FDA approval for its Investigational Device Exemption application. This approval clears the way for the SPIRARE II U.S. pivotal study (NCT06576427) to advance, marking a significant milestone for the company’s novel approach to catheter-based interventions.
The SPIRARE II pivotal trial will evaluate the Vertex Pulmonary Embolectomy System, which integrates Jupiter’s Endoportal Control™ technology to enhance precision and control in treating Acute Pulmonary Embolism (PE). This innovative approach aims to improve access and stability for catheter-based interventions in areas that are challenging to reach with conventional methods. The system operates by delivering the device in a flexible state over a guidewire, pressurizing it with saline to secure its position for treatment, and then relaxing it to navigate or remove.
The SPIRARE II trial is a prospective, single-arm, multicenter study enrolling up to 145 patients across 25 U.S. sites. It will assess the procedural and clinical benefits of using the Vertex system with Endoportal Control™, focusing on safety, right heart function, and clinical improvement from the procedure to 30 days post-treatment. This trial is part of Jupiter Endovascular’s broader SPIRARE clinical program, which also includes the SPIRARE I study in Europe.
Catalin Toma, MD, Director of Interventional Cardiology at UPMC and national co-principal investigator, highlights the challenge of navigating through the right heart and pulmonary vasculature with current stiff catheters, which can stress the right ventricle and hinder precise control. Joshua Goldberg, MD, Surgical Director at Weill Cornell Medical Center, emphasizes the advantage of Endoportal Control™ in providing the control and stability akin to open surgery, potentially enhancing procedural safety and efficacy.
Jupiter Endovascular CEO Carl J. St. Bernard expressed excitement over the FDA approval, noting that Endoportal Control™ has shown promising results in animal studies and could revolutionize endovascular procedures. The Vertex system represents the first of many planned innovations leveraging this technology to address various cardiovascular conditions.
Pulmonary embolism, a blockage in the lungs caused by blood clots, is a major health issue, with up to 900,000 cases annually in the U.S. and a significant mortality rate within the first month of diagnosis.
About Jupiter Endovascular
Jupiter Endovascular is pioneering the “endoportal procedure,” a novel class of endovascular techniques using Endoportal Control™. This approach provides surgical-like precision and control through catheter-based interventions, aiming to improve treatment outcomes for various cardiovascular conditions.
