Medtronic has enrolled the first patient in the PEripheral Onyx Liquid Embolic (PELE) clinical trial, marking a significant milestone in the company's efforts to expand the use of its Onyx Liquid Embolic System (LES) for treating arterial hemorrhage in peripheral vasculature within the United States. The inaugural procedure was performed by Dr. Christopher Stark at Albany Medical Center.
Study Design and Objectives
The PELE IDE Clinical Study is designed as a pivotal, prospective, multi-center, non-randomized, single arm study that will enroll up to 119 patients from up to 25 sites across the U.S. The trial will evaluate the safety and effectiveness of Onyx LES in treating subjects with active arterial bleeding in the peripheral vasculature who are deemed suitable for embolization treatment. In this study, peripheral vasculature is specifically defined as areas outside of the brain and heart.
The primary safety and efficacy endpoints will be evaluated through 30 days following treatment with Onyx LES, providing crucial data for regulatory review.
Clinical Application and First Case
"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 Christopher Stark, M.D., vascular and interventional radiologist at Albany Medical Center.
Dr. Stark emphasized the significance of the study, stating, "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 treatment of peripheral arterial hemorrhage."
Regulatory Strategy and Market Access
The trial represents a critical step in Medtronic's regulatory strategy for the U.S. market. "Onyx LES is available with a peripheral indication in many markets outside the U.S.," said David Moeller, president of the Peripheral Vascular Health business, which is part of the Cardiovascular Portfolio at Medtronic. "This trial will generate the evidence necessary for U.S. physicians to use Onyx for embolization of arterial hemorrhage in the peripheral vasculature, a key part of advancing our embolic portfolio strategy."
Currently, the use of Onyx LES for embolization of arterial hemorrhage in the peripheral vasculature is investigational in the United States and has not been approved or cleared by the U.S. Food and Drug Administration.
Building on Global Experience
The PELE IDE Clinical Study will build upon extensive commercial experience from the use of Onyx LES in the peripheral vasculature globally. The trial aims to provide the necessary evidence to add Onyx LES to the U.S. portfolio of peripheral vasculature embolization products from Medtronic, potentially expanding treatment options for patients with arterial hemorrhage in peripheral vessels.
