Medtronic (NYSE: MDT) today announced the first patient enrolled in the PELE trial of its Onyx liquid embolic system (LES).
PELE (Peripheral Onyx Liquid Embolic) evaluates the safety of Onyx LES for the embolization of arterial hemorrhage in the peripheral vasculature. Dr. Christopher Stark performed the first procedure at Albany Medical Center.
Onyx LES, an ethylene vinyl alcohol (EVOH) copolymer provides complete filling and distal penetration of peripheral lesions. It is delivered through a microcatheter under fluoroscopic control. The system’s non-adhesive properties enable more distal nidus embolization without the risk of catheter entrapment. Additionally, higher viscosities allow for controlled deployment.
Investigators plan to enroll up to 119 patients from up to 25 U.S. sites, evaluating the primary safety and efficacy endpoints through 30 days. The study includes subjects with active arterial bleeding in the peripheral vasculature deemed suitable for embolization treatment. In this case, investigators define peripheral vasculature as outside of the brain and heart.
Medtronic plans to use data from the study to demonstrate the benefits of Onyx LES and add the system to its portfolio of peripheral vasculature embolization products. Onyx LES for embolization of arterial hemorrhage in the peripheral vasculature remains investigational in the U.S.
“Onyx LES is available with a peripheral indication in many markets outside the U.S. 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,” said David Moeller, president of the Peripheral Vascular Health business at Medtronic.
