Jupiter Endovascular announced its Vertex catheter received FDA 510(k) clearance for the insertion of endovascular devices.
According to the FDA 510(k) database, the agency received Jupiter Endovascular’s submission on June 30. It delivered the clearance on Sept. 12.
The company took to LinkedIn to announce the regulatory milestone:
“FDA Cleared! Our Vertex catheter just received 510(k) clearance for the insertion of endovascular devices,” the company wrote. “Vertex is the first and only FDA-cleared intravascular device with Transforming Fixation (TFX) — able to shift from flexible to firm on demand, giving physicians true stability and control.”
Related: Novocuff announces FDA IDE approval for a study of its Cervical Control System
The company also said it expects “even bigger” updates for the company this fall. (Read more about the Vertex catheter at Medical Design & Outsourcing.)
Jupiter’s Vertex catheter comprises part of the vertex system designed to treat acute pulmonary embolism (PE). The innovative endovascular procedure offers high levels of control and precision. Menlo Park, California-based Jupiter received FDA investigational device exemption for Vertex in August 2024. It announced the first cases with the system a month later.
The company developed its Endoportal Control technology to bring these benefits to a variety of catheter interventions. Jupiter Endovascular, which spun out of Neptune Medical last year, 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.
