SPIRARE II U.S. Pivotal Trial Commences Studying System Designed to Bring the Precision and Control of Direct Surgical Access to Catheter-Based Interventions
MENLO PARK, Calif.--(BUSINESS WIRE)--#FDA--Jupiter Endovascular, Inc., a medical technology startup developing a new class of endovascular procedures using Endoportal Control™, announced today that the first U.S. patient has been treated in the SPIRARE II U.S. 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 innovative endovascular procedure offering an unprecedented level of control and precision.
The first U.S. case was performed at Staten Island University Hospital, Northwell Health by Mitchell Weinberg, MD, Chair of Cardiology, and Vincent Gallo, MD, Director of Vascular and Interventional Radiology.
“The unique maneuverability 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 stabilize 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 Dr. 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 U.S. procedure,” said Dr. Gallo.
SPIRARE II is a prospective, single-arm, multicenter pivotal trial that will enroll up to 145 patients with acute, intermediate-risk PE treated with the Vertex Pulmonary Embolectomy System at up to 25 U.S. sites. Trial endpoints will characterize 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 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.”
About Jupiter Endovascular
Jupiter Endovascular is a medical technology startup developing the “endoportal procedure,” a new class of endovascular interventions using Endoportal Control™ to bring the precision and control of direct surgical access to catheter-based therapies. The procedure uses an endoportal device that navigates flexibly through the vasculature via percutaneous access. Once in position, the endoportal device can be fixed into a stable state to deliver an interventional treatment with surgical-like precision and control from an endovascular access point. To learn more about Jupiter Endovascular, visit www.jupiterendo.com.
Contacts
MEDIA CONTACT:
Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com
(310) 902-1274
