Jupiter Endovascular Commences Vertex System’s SPIRARE II US Pivotal Trial

October 25, 2024—Jupiter Endovascular, Inc. announced that the first patient has been treated in the SPIRARE II United States pivotal study of the Vertex pulmonary embolectomy system. The Vertex system, which features the company’s Endoportal Control platform technology, is designed to treat acute pulmonary embolism (PE) in an endovascular procedure.

The company recently announced FDA approval of its application for an investigational device exemption for the SPIRARE II study.

According to the company, the prospective, single-arm, multicenter SPIRARE II pivotal trial will enroll up to 145 patients with acute, intermediate-risk PE treated with the Vertex 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 post procedure, stated the company.

The first procedure in the trial was performed by Mitchell Weinberg, MD, Chair of Cardiology, and Vincent Gallo, MD, Director of Vascular and Interventional Radiology, at Staten Island University Hospital, Northwell Health in Staten Island, New York.

“The unique maneuverability of the large-bore Vertex endoportal device enabled us to easily navigate across multiple bends through the right heart and into the pulmonary arteries,” commented Dr. Weinberg in the company’s press release. “Once in the pulmonary arteries, the technology allowed us to stabilize the endoportal device, creating a secure base for us to safely advance the aspiration catheter deep within the pulmonary vasculature and capture hard-to-reach thrombi. With Endoportal Control, we achieved an excellent procedural result with remarkable speed and ease, especially given that it was our first time using this technology.”

Dr. Gallo added, “Navigating the pulmonary arteries can be challenging and often requires a complex trial-and-error approach involving multiple guidewires and ancillary devices in order to safely reach the target vessels. Using Endoportal Control with the Vertex system, we eliminated many of these extra steps and device exchanges, resulting in a much simpler procedure that allowed us to focus less on gaining vessel access and more on treating the patient. Our team is very excited to study this technology further, and I would like to thank Brandon Dilluvio on our team for his support in facilitating this first United States procedure.”