Medtronic has enrolled the first patient in the PELE clinical trial to evaluate the Onyx Liquid Embolic System (LES) for arterial haemorrhage embolisation in peripheral vasculature.
The initial procedure was conducted by Dr Christopher Stark at Albany Medical Centre, marking a significant step in assessing the system’s safety and effectiveness.
The PELE IDE Clinical Study aims to assess the Onyx LES for treating active arterial bleeding in peripheral vasculature, defined as outside the brain and heart.
It is a prospective, multi-centre, non-randomised, and single-arm study, intended to enrol up to 119 patients across 25 sites in the US.
Primary safety and efficacy endpoints will be evaluated within 30 days post-treatment.
Albany Medical Centre vascular and interventional radiologist Christopher Stark said: “Embolic agents are an important tool to address haemorrhage.
“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 embolisation.
“Albany Medical Centre 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 haemorrhage.”
The Onyx LES is an ethylene vinyl alcohol (EVOH) copolymer dissolved in dimethyl sulfoxide (DMSO) with suspended micronised tantalum powder, for peripheral embolisation.
Delivered through a microcatheter under fluoroscopic control, it flows like lava and solidifies from the outside in as solvent diffuses away.
Its non-adhesive properties permit more distal nidus embolisation without significant risk of catheter entrapment, while higher viscosities allow for controlled deployment.
The study will leverage commercial experience with Onyx LES in peripheral vasculature to provide evidence for its inclusion in Medtronic’s US portfolio of embolisation products.
Currently, the use of Onyx LES for arterial haemorrhage embolisation is investigational in the US and has not received approval from the US Food and Drug Administration.
Medtronic will use the study results to build a foundation for future regulatory clearance.
Medtronic peripheral vascular health business president David Moeller said: “Onyx LES is available with a peripheral indication in many markets outside the US.
“This trial will generate the evidence necessary for US physicians to use Onyx for embolisation of arterial haemorrhage in the peripheral vasculature, a key part of advancing our embolic portfolio strategy.”
Recently, Medtronic obtained the CE mark for its LigaSure RAS vessel-sealing technology, enhancing the capabilities of the Hugo robotic-assisted surgery (RAS) system.
