Jupiter Endovascular has received the US Food and Drug Administration (FDA) approval for the Investigational Device Exemption (IDE) study of its Vertex Pulmonary Embolectomy System.
The US-based medical technology company is developing new endovascular procedures using its Endoportal Control technology to bring precision and control to catheter-based interventions.
The IDE study, dubbed SPIRARE II US study, will evaluate the Vertex System, featuring Jupiter’s Endoportal Control platform technology.
Endoportal Control is designed to help interventionalists deliver treatment to anatomical sites that they cannot safely or easily reach with a conventional endovascular approach.
Jupiter will use the technology in an endovascular procedure to treat Acute Pulmonary Embolism (PE) with a superior level of control and precision.
Jupiter endovascular CEO Carl St. Bernard said: “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.
“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.”
SPIRARE II is a single-arm, multicentre clinical trial designed to enrol up to 145 patients with acute, intermediate-risk PE treated with the Vertex system, at up to 25 sites in the US.
The endpoints of the clinical trial include the procedural and clinical benefits of PE treatment with Endoportal Control using the Vertex system.
The benefits are measured across safety, right heart function, and clinical improvement from the time of the procedure to 30 days post-procedure.
SPIRARE II is part of Jupiter Endovascular’s SPIRARE clinical programme, which also includes the SPIRARE I clinical study evaluating the Vertex system at up to two sites in Europe.
SPIRARE II national co-principal investigator Joshua Goldberg said: “In open surgery, we have the benefit of being able to directly visualize the anatomy and the instruments with which we are working. This provides surgeons with an excellent level of control and precision.
“A percutaneous embolectomy system that can provide interventionalists with the control and stability we enjoy in surgery holds the potential to dramatically improve procedural safety, efficacy, and efficiency.”
