Jupiter Endovascular Nabs IDE Nod for Vertex Pulmonary Embolectomy Trial

Jupiter Endovascular has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for its SPIRARE II U.S. pivotal study.
 
The trial will evaluate the company’s Vertex pulmonary embolectomy system, which incorporates the novel Endoportal Control platform technology into an endovascular procedure to treat acute pulmonary embolism (PE). Endoportal Control was designed to help interventionalists deliver catheter-based treatment to anatomical sites they can’t 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. It’s then pressurized with saline to fix it in a stable position for therapeutic delivery, and relaxed again to navigate to another location or for removal.
 
The SPIRARE II trial will enroll up to 145 patients with acute, intermediate-risk PE. These subjects will be treated with the Vertex PE system at up to 25 sites in the U.S.
 
Trial endpoints will consist of safety, right heart function, and clinical improvement from the time of procedure to 30 days after. SPIRARE II is part of Jupiter Endovascular’s SPIRARE clinical program, which includes the SPIRARE I study evaluating Vertex at up to two European sites.
 
“We are excited about FDA approval of the first pivotal study of a system leveraging our Endoportal Control platform technology. In the more than 25 animal studies conducted to-date with the technology, it has demonstrated safe and easy navigation through the heart and vasculature, and effective delivery of test interventions,” said Carl J. St. Bernard, Jupiter Endovascular’s CEO. “Endoportal Control has the potential to meaningfully improve many endovascular procedures while enabling entirely new therapies. Our Vertex system for pulmonary embolectomy is the first of what we intend to be a portfolio of our own interventional procedure systems incorporating Endoportal Control to treat a variety of cardiovascular conditions that affect millions of patients worldwide.”
 
St. Bernard was appointed the company’s CEO earlier this month. Jupiter also exited stealth mode with a new $21 million round of financing.