Jupiter Endovascular Receives FDA Approval for U.S. Pivotal Study of Vertex Pulmonary Embolectomy System Using Endoportal Control

Excerpt from the Press Release:

MENLO PARK, Calif.–(BUSINESS WIRE)–Jupiter Endovascular, Inc., a medical technology startup developing a new class of endovascular procedures using Endoportal Control™ to bring the precision and control of direct surgical access to catheter-based interventions, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption application for the SPIRARE II U.S. pivotal study (NCT06576427).

The pivotal trial will study the Vertex Pulmonary Embolectomy System, which incorporates Jupiter’s novel Endoportal Control™ platform technology into an innovative endovascular procedure intended to treat Acute Pulmonary Embolism (PE) with an unprecedented level of control and precision. Endoportal Control™ is designed to bring these benefits to a variety of catheter interventions, with the goal of enabling interventionalists to deliver treatment to anatomical sites that they cannot safely or easily reach with a conventional endovascular approach. The endoportal device is delivered in a flexible, relaxed state over a guidewire to the target location in the vasculature, pressurized with saline to fix it in a stable position for therapeutic delivery, then relaxed again to navigate to another target location or for removal.

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 U.S. sites. 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.

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