Jupiter Endovascular Receives IDE Approval for SPIRARE II Pivotal Trial

September 10, 2024—Jupiter Endovascular, Inc., announced recently that the FDA has approved the company’s application for an investigational device exemption (IDE) for the SPIRARE II pivotal study in the United States. Jupiter Endovascular is a medical technology startup company based in Menlo Park, California.

According to the company, the SPIRARE II trial will study Jupiter’s Vertex pulmonary embolectomy system, which incorporates the company’s Endoportal Control platform technology into an endovascular procedure intended to treat acute pulmonary embolism (PE). Endoportal Control technology is being developed to bring the precision and control of direct surgical access to catheter-based interventions. The technology aims to enable interventionalists to deliver treatment to anatomical sites that they cannot safely or easily reach with a conventional endovascular approach.

Jupiter Endovascular stated that SPIRARE II is a prospective, single-arm, multicenter pivotal trial that will enroll up to 145 patients with acute, intermediate-risk PE treated with the Vertex pulmonary embolectomy system at up to 25 sites in the United States.

Trial endpoints will characterize the procedural and clinical benefits of PE treatment 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.

Jupiter Endovascular’s SPIRARE clinical program also includes the SPIRARE I clinical study evaluating the Vertex system at up to two sites in Europe, advised the company.

Catalin Toma, MD, said Joshua Goldberg, MD, are National Coprincipal Investigators of the SPIRARE II trial. Dr. Toma is Director of Interventional Cardiology for the Heart and Vascular Institute at the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania. Dr. Goldberg is Surgical Director of the Structural Heart Surgery Program at Weill Cornell Medical Center in New York, New York.

“One of the remaining challenges in treating PE is the ability to safely navigate through the right heart and into multiple areas of the pulmonary vasculature,” commented Dr. Toma in Jupiter Endovascular’s press release. “The act of placing stiff interventional devices across the right heart may add stress to a strained right ventricle, and today’s catheters can become difficult to purposefully control beyond the main pulmonary arteries. These risks pose a barrier to the widespread adoption of large-bore catheter therapies for PE, creating the need for a procedural system that can safely access the pulmonary arteries with increased control.”

Dr. Goldberg added, “In open surgery, we have the benefit of being able to directly visualize the anatomy and the instruments with which we are working. This provides surgeons with an excellent level of control and precision. A percutaneous embolectomy system that can provide interventionalists with the control and stability we enjoy in surgery holds the potential to dramatically improve procedural safety, efficacy, and efficiency.”