Medtronic Commences PELE Pivotal Study of Onyx Liquid Embolic System in Peripheral Vasculature

July 16, 2025—Medtronic announced that the first patient has been enrolled in PELE, the Peripheral Onyx Liquid Embolic clinical trial. The investigational device exemption (IDE) trial will evaluate the safety and effectiveness of the company’s Onyx liquid embolic system (LES) for embolization of arterial hemorrhage in the peripheral vasculature.

According to the company, data from the pivotal PELE IDE clinical study are intended to evaluate the safety and effectiveness of Onyx LES in the treatment of patients with active arterial bleeding in the peripheral vasculature who are deemed suitable for embolization treatment. In this study, peripheral vasculature is defined as outside of the brain and heart, noted Medtronic.

The company stated that the prospective, multicenter, nonrandomized, single-arm study will enroll up to 119 patients at up to 25 sites in the United States. The primary safety and efficacy endpoints will be evaluated through 30 days after treatment with Onyx LES.

Medtronic advised that 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 FDA. The PELE study will build upon the global commercial experience with the Onyx LES in the peripheral vasculature to provide the evidence to support an FDA submission.

The first procedure was performed by vascular and interventional radiologist Christopher Stark, MD, at Albany Medical Center in Albany, New York.

“Embolic agents are an important tool to address hemorrhage,” commented Dr. Stark in the company’s press release. “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.

“Albany Medical Center is proud to be enrolling patients in the PELE IDE clinical study, the aim of which is to gather evidence to support the safety and efficacy of Onyx LES in the treatment of peripheral arterial hemorrhage.”