Medtronic Initiates New Indication Study for Onyx LES Liquid Embolic System in Peripheral Arterial Hemorrhage

Medtronic Announces CompletionLiquid Embolic AgentOnyx LESTheFirst Patient Enrolled in PELE Clinical Study.PELE Clinical StudyAiming to EvaluateOnyx LESSafety and Effectiveness for Peripheral Vascular System Arterial Hemorrhage Embolization. The first procedure was performed by Dr. Christopher Stark at Albany Medical Center.

PI Evaluation

"Embolic agents are crucial tools for addressing bleeding issues. In this case, the patient experienced bleeding due to vascular rupture following a routine medical procedure. We successfully achieved embolization by injecting Onyx LES into the target vessel. Albany Medical Center is honored to participate in enrolling patients into the PELE IDE clinical study, which aims to gather evidence supporting the safety and efficacy of Onyx LES in treating peripheral arterial bleeding."

Executive Evaluation

"In many markets outside the United States, Onyx LES has been approved for peripheral indications, and this trial will generate the necessary evidence to enable U.S. physicians to use Onyx for embolization of arterial bleeding in the peripheral vasculature, which is a key part of our strategy to advance the embolic product portfolio."

---David Moeller  President of Peripheral Vascular Health Division, Medtronic Cardiovascular Business Portfolio

PELE IDE Clinical Study will be built onOnyx LESBased on extensive commercial experience with global peripheral vascular system applications. It aims to provide the necessary evidence toOnyx LESAdded to Medtronic's peripheral vascular system embolization product portfolio in the United States.

Onyx LES

Onyx LESIt is a non-adhesive liquid embolic agent (LEA) based on ethylene-vinyl alcohol (EVOH) copolymer. Its main components are a mixture of ethylene-vinyl alcohol copolymer (EVOH), dimethyl sulfoxide (DMSO), and suspended micronized tantalum powder, where EVOH is the primary component, DMSO acts as the solvent, and the tantalum powder enhances its visibility under X-rays.

Onyx LESProvides complete filling and distal penetration for peripheral lesions. It is delivered through a microcatheter under fluoroscopic guidance. The non-adhesive nature of the system allows for more distal lesion embolization without the risk of catheter retention. Additionally, higher viscosity enables controlled deployment.

Onyx LES has two formulations.

• Onyx 18 LES (6% EVOH, Viscosity 18cSt): Lower viscosity allows it to flow further and penetrate deeper into the target lesion;

• Onyx 34 LES (8% EVOH, Viscosity 34cSt): Higher viscosity provides greater control in higher blood flow and larger fistula components.

Onyx LES Polymer Properties

• Precipitation occurs upon contact with aqueous solutions (such as blood, water, contrast agents);

• Flowing like lava, solidifying from the outside in as the solvent diffuses;

• Delivered in a cohesive manner, forming a sponge-like, continuous plug.