Investigators treated two patients in the SPIRARE I study of the Vertex system using the company’s Endoportal Control platform technology. Dr. Grzegorz Kopec, Dr. Jakub Stepniewski, and Dr. Krzysztof Bartus performed the successful cases. They took place at St. John Paul II Hospital in Krakow, Poland.
SPIRARE I evaluates patients with acute, intermediate-risk PE treated with Vertex. Trial endpoints will characterize the procedural and clinical benefits of PE treatment with Vertex and Endoportal Control. They range across safety measures, right heart function and clinical improvement from time of procedure to 30 days post-procedure.
Kopec reported success with Vertex in safely navigating through the right heart and into the pulmonary vasculature. He said Vertex facilitated an efficient and effective pulmonary embolectomy with no safety issues.
“The Endoportal technology enabled the large-bore Vertex system to remain stable in tachypneic patients, allowing us to quickly access and revascularize multiple areas of the pulmonary vasculature in a controlled manner when facing a high degree of cardiorespiratory movement,” said Stepniewski.
More about the Jupiter Endovascular Vertex system
Menlo Park, California-based Jupiter designed its Vertex system to treat acute pulmonary embolism (PE). The innovative endovascular procedure offers high levels of control and precision. It received FDA investigational device exemption in August.
The company developed its Endoportal Control technology to bring these benefits to a variety of catheter interventions. Jupiter Endovascular, which only came out of stealth mode, spinning out of Neptune Medical last month, aims 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. It’s pressurized with saline to fix it in a stable position for therapeutic delivery, then relaxed again to navigate to another target or for removal.
“We are delighted with the performance of our technology in these first two cases, demonstrating safe access and the ability to bring a high degree of precision and control to the successful treatment of these patients with intermediate-risk pulmonary embolism,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “As the first step in our SPIRARE clinical program, we look forward to validating these positive results more broadly in this study and in the upcoming SPIRARE II pivotal trial, as well as to expanding the potential benefits of our Endoportal Control platform technology to additional clinical areas where we intend to improve the lives and well-being of many patients.”
