Jupiter Endovascular has announced that the first US patient has been treated in the SPIRARE II US pivotal study of the Vertex pulmonary embolectomy system featuring the company’s Endoportal control platform technology.
The Vertex system is designed to treat acute pulmonary embolism (PE) in an endovascular procedure offering an “unprecedented level of control and precision”, according to the company.
The first US case was performed at Staten Island University Hospital, Northwell Health (New York, USA) by Mitchell Weinberg and Vincent Gallo.
“The unique manoeuvrability of the large-bore Vertex endoportal device enabled us to easily navigate across multiple bends through the right heart and into the pulmonary arteries. Once in the pulmonary arteries, the technology allowed us to stabilise the endoportal device, creating a secure base for us to safely advance the aspiration catheter deep within the pulmonary vasculature and capture hard-to-reach thrombi. With Endoportal Control, we achieved an excellent procedural result with remarkable speed and ease, especially given that it was our first time using this technology,” said Weinberg.
“Navigating the pulmonary arteries can be challenging and often requires a complex trial-and-error approach involving multiple guidewires and ancillary devices in order to safely reach the target vessels. Using Endoportal Control with the Vertex system, we eliminated many of these extra steps and device exchanges, resulting in a much simpler procedure that allowed us to focus less on gaining vessel access and more on treating the patient. Our team is very excited to study this technology further, and I would like to thank Brandon Dilluvio on our team for his support in facilitating this first US procedure,” said Gallo.
SPIRARE II is a prospective, single-arm, multicentre pivotal trial that will enrol up to 145 patients with acute, intermediate-risk PE treated with the Vertex pulmonary embolectomy system at up to 25 US sites. Trial endpoints will characterise the procedural and clinical benefits of PE treatment with Endoportal Control using the Vertex system, across measures of safety, right heart function, and clinical improvement from the time of the procedure to 30 days post-procedure.
The company’s Endoportal Control platform technology integrated into the Vertex system is designed to bring greater ease and stability to a variety of catheter interventions, with the goal of enabling interventionalists to treat anatomical sites that they cannot safely or easily reach with a conventional endovascular approach. The endoportal device is delivered in a flexible, relaxed state over a guidewire to a target location in the vasculature, pressurized with saline to fix it in a stable position for therapeutic delivery, then relaxed again to navigate to another target location or for removal.
“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. 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 USA could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”
