FDA approves study assessing pulmonary embolectomy system with Endoportal Control
Click Here to Manage Email Alerts
The FDA approved the SPIRARE II trial set to evaluate the use of Jupiter Endovascular’s Vertex Pulmonary Embolectomy System with Endoportal Control in patients with acute pulmonary embolism, according to a press release.
“SPIRARE opens the door for a new generation of large-bore interventional technology, designed for increased safety and reduced hemodynamic footprint, as well as for improved control in the more distal pulmonary vasculature,” Catalin Toma, MD, national co-principal investigator of SPIRARE II and director of interventional cardiology for the Heart and Vascular Institute at the University of Pittsburgh Medical Center, told Healio.
According to the release, the Vertex Pulmonary Embolectomy System (Jupiter Endovascular) is a catheter-based endovascular procedure, and the addition of Endoportal Control (Jupiter Endovascular) helps clinicians achieve control and precision in therapeutic delivery or removal within the vasculature during the procedure.
In the prospective, single-arm, multicenter investigational device exemption trial, the release noted that researchers will assess around 145 patients with acute, intermediate-risk pulmonary embolism to determine how the Vertex Pulmonary Embolectomy System with Endoportal Control impacts patients’ right ventricle to left ventricle ratio at 30 days after the procedure.
Toma also told Healio that the trial will analyze whether the procedure is safe and the impact it has on hemodynamics.
“In addition to demonstrating the safety and efficacy of this novel embolectomy system, it is my hope that this trial will demonstrate that this improved technology will more safely and reliably traverse the heart and the pulmonary arteries,” Joshua Goldberg, MD, national co-principal investigator of SPIRARE II and surgical director of the structural heart surgery program at Weill Cornell Medical Center in New York, told Healio.
When asked why this trial is important for those treating pulmonary embolism, Goldberg told Healio that clinicians encounter two problems with current catheter-based thrombectomy systems when navigating though the right heart.
“First, they are stiff and therefore can have an adverse hemodynamic impact by distorting the anatomy,” Goldberg said. “Second, complex anatomy can prove challenging to the clinician in terms of safe, efficient and effective access in a stable manner.
“This novel technology can solve these problems and result in a safer and easier catheter-based procedure,” Goldberg added.
According to Carl J. St. Bernard, CEO of Jupiter Endovascular, enrollment for this trial is expected to start “later this year.”
“We anticipate clinical trial results to be presented at a major conference following the completion of the SPIRARE II trial,” St. Bernard told Healio.
Additionally, a similar trial, SPIRARE I, is taking place in Europe, St. Bernard said. On Sept. 19, the company announced successful treatment of the first patients in a press release.
Reference:
- Jupiter Endovascular announces first patients successfully treated in first clinical study of Vertex Pulmonary Embolectomy System using Endoportal Control. https://jupiterendo.com/jupiter-endovascular-announces-first-patients-successfully-treated-in-first-clinical-study-of-vertex-pulmonary-embolectomy-system-using-endoportal-control/. Published Sept. 19, 2024. Accessed Sept. 24, 2024.