Medtronic Begins Onyx Liquid Embolic IDE Study

Medtronic has enrolled the first patient in its PEripheral Onyx Liquid Embolic (PELE) clinical trial, which will evaluate its Onyx liquid embolic system (LES) for embolization of arterial hemorrhage in the peripheral vasculature.

Data from the PELE IDE clinical study will assess Onyx LES’ safety and effectiveness to treat subjects with active arterial bleeding in the peripheral vasculature deemed suitable for embolization treatment. Peripheral vasculature in this study is defined as outside the brain and heart.

The pivotal, prospective, multi-center, non-randomized, single arm study will enroll up to 119 patients from up to 25 U.S. sites. Primary safety and efficacy endpoints will be evaluated through 30 days after treatment with Onyx LES.

The first procedure in the trial was performed by Dr. Christopher Stark at Albany Medical Center.

“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 Dr. Stark, who is a vascular and interventional radiologist at Albany Medical Center. “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.”

The study will build on commercial experience from using Onyx LES in the peripheral vasculature globally. It aims to provide the necessary evidence to add Onyx LES to the U.S. portfolio of peripheral vasculature embolization products from Medtronic.

“Onyx LES is available with a peripheral indication in many markets outside the U.S.,” said David Moeller, president of Medtronic’s Peripheral Vascular Health business. “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.”

Earlier this week, the company revealed it had received CE mark approval for its LigaSure RAS vessel-sealing technology, expanding its Hugo robotic-assisted surgery (RAS) system capabilities for gynecologic, general, and urologic procedures in Europe.