Medtronic today announced that the first patient has been enrolled in the Peripheral Onyx liquid embolic (PELE) clinical trial, which will evaluate the safety and effectiveness of the Onyx liquid embolic system (LES) for embolization of arterial hemorrhage in the peripheral vasculature. The first procedure was performed by Christopher Stark, MD, a vascular and interventional radiologist at Albany Medical Center in Albany, New York.
Data from the PELE investigational device exemption (IDE) clinical study is intended to evaluate the safety and effectiveness of Onyx LES in the treatment of patients with active arterial bleeding in the peripheral vasculature that are deemed suitable for embolization treatment. In this study, peripheral vasculature is defined as outside of the brain and heart.
“Embolic agents are an important tool to address hemorrhage. In this case, the patient experienced bleeding due to a ruptured blood vessel following a routine medical procedure. Onyx LES was administered into the target vessel to successfully facilitate embolization,” said Stark.
This pivotal, prospective, multicenter, non-randomized, single-arm study will enroll up to 119 patients from up to 25 sites in the U.S. The primary safety and efficacy endpoints will be evaluated through 30 days following treatment with Onyx LES.
Medtronic advises that, in the U.S., the use of Onyx LES for embolization of arterial hemorrhage in the peripheral vasculature is investigational and has not been approved or cleared by the Food and Drug Administration (FDA).
