Medtronic has announced the first subject enrolment in the Peripheral Onyx Liquid Embolic (PELE) trial.
The study aims to assess the effectiveness and safety of Onyx’s liquid embolic system (LES) for embolising arterial haemorrhage in the peripheral vasculature, defined as the region outside of the brain and heart.
The first procedure was performed by Dr Christopher Stark, a vascular and interventional radiologist at the Albany Medical Center.
The pivotal, non-randomised, prospective, multi-centre, and single-arm PELE investigational device exemption (IDE) trial is set to enrol up to 119 subjects across up to 25 US sites.
Data from this study is intended to assess the Onyx LES to treat patients with active arterial bleeding in the peripheral vasculature who are considered suitable for embolisation treatment. 聽
The primary safety and efficacy goals will be assessed 30 days post-treatment with the Onyx system.
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By GlobalDataMedtronic noted that the study is set to build on the global commercial experience with the system in the peripheral vasculature.
It seeks to offer evidence to support the inclusion of Onyx LES in Medtronic’s US portfolio of peripheral vasculature embolisation products.
Currently, Onyx LES is investigational in the US and has not received approval from the US Food and Drug Administration (FDA).
The system is a radiopaque, pre-mixed, injectable embolic fluid tailored for complete filling and distal penetration.
It consists of ethylene vinyl-alcohol copolymer (EVOH), dimethyl-sulfoxide (DMSO) and micronised tantalum powder (TA).
Medtronic cardiovascular portfolio鈥檚 peripheral vascular health business president David Moeller said: 鈥淥nyx LES is available with a peripheral indication in many markets outside the US.
鈥淭his 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.鈥�
Before this, Medtronic obtained EU CE mark approval for LigaSure RAS, a vessel-sealing instrument designed for use with the Hugo robotic-assisted surgery (RAS) system.
