The first U.S. patient treated follows last month’s announcement of the first Vertex use in the SPIRARE I study in Poland. SPIRARE II evaluates the Vertex pulmonary embolectomy system in the treatment of acute pulmonary embolism (PE). Dr. Mitchell Weinberg and Dr. Vincent Gallo performed the first U.S. case at Staten Island University Hospital, Northwell Health.
Menlo Park, California-based Jupiter designed its Vertex system with EndoPortal Control to treat acute PE with high levels of control and precision. It received FDA investigational device exemption in August.
The company developed its Endoportal Control technology to enable interventionalists to deliver treatment to anatomical sites that can’t be safely or easily reached through conventional endovascular approaches.
Jupiter designed the Endoportal device for delivery in a flexible, relaxed state. It goes over a guidewire to the target location in the vasculature. Pressurized with saline, it fixes in a stable position for therapeutic delivery. It then relaxes again to navigate to another target or for removal.
The company expects SPIRARE II to enroll up to 145 patients across 25 U.S. sites. The study aims to evaluate measures of safety, right heart function and clinical improvement from time of procedure to 30 days post-procedure.
“We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”