Jupiter Endovascular, Inc., a medical technology startup focused on pioneering endovascular procedures with its Endoportal Control™ platform, has announced the successful treatment of the first U.S. patient in the SPIRARE II pivotal study. This study evaluates the Vertex Pulmonary Embolectomy System, which aims to address Acute Pulmonary Embolism (PE) through a novel endovascular approach that delivers exceptional control and precision.
The first U.S. case using the Vertex Pulmonary Embolectomy System was successfully performed at Staten Island University Hospital, Northwell Health, by Dr. Mitchell Weinberg, Chair of Cardiology, and Dr. Vincent Gallo, Director of Vascular and Interventional Radiology.
Dr. Weinberg remarked, “The maneuverability of the large-bore Vertex endoportal device allowed us to navigate multiple bends through the right heart and into the pulmonary arteries with ease. Once in position, the technology enabled us to stabilize the device, creating a secure base to advance the aspiration catheter deep into the pulmonary vasculature and capture difficult-to-reach thrombi. With Endoportal Control, we achieved excellent results quickly and efficiently, especially as it was our first use of this technology.”
Dr. Gallo added, “Navigating the pulmonary arteries can be complex, often requiring a trial-and-error approach with multiple guidewires and devices. The Vertex system with Endoportal Control simplified this process, reducing the need for extra steps and device exchanges. This allowed us to focus more on patient care. We’re excited to further explore this technology, and I’d like to thank Brandon Dilluvio for his support during this first U.S. procedure.”
The SPIRARE II trial is a prospective, single-arm, multicenter pivotal study aimed at enrolling up to 145 patients with acute, intermediate-risk pulmonary embolism (PE) across 25 U.S. sites. The trial will assess the procedural and clinical benefits of using the Vertex Pulmonary Embolectomy System, focusing on safety, right heart function, and clinical improvements from the procedure to 30 days post-treatment.
The Endoportal Control platform technology integrated into the Vertex system enhances the stability and ease of catheter interventions, enabling interventionalists to access anatomical sites that are typically difficult to reach with standard endovascular techniques. The device is delivered over a guidewire in a flexible state, pressurized with saline to stabilize it, and can then be navigated to other locations or removed as needed.
Carl J. St. Bernard, CEO of Jupiter Endovascular, stated, “Navigation challenges in endovascular procedures are often underestimated, leading to lower adoption of critical treatments like pulmonary embolectomy. Our Endoportal Control technology aims to address these issues, making vital procedures accessible to more clinicians and patients. This first U.S. case has validated the safety and performance observed in our ongoing European SPIRARE I study.”
About Jupiter Endovascular
Jupiter Endovascular is a medical technology startup focused on developing the “endoportal procedure,” a novel class of endovascular interventions that utilize Endoportal Control™. This approach aims to combine the precision and control of surgical access with catheter-based therapies, using a flexible endoportal device that navigates through the vasculature and can be stabilized for precise therapeutic delivery.
