Medtronic today announced that the first patient has been enrolled in the Peripheral Onyx liquid embolic (PELE) clinical trial, which will evaluate the safety and effectiveness of the Onyx liquid embolic system (LES) for embolisation of arterial haemorrhage in the peripheral vasculature. The first procedure was performed by Christopher Stark at Albany Medical Center (Albany, USA).
Data from the PELE investigational device exemption (IDE) clinical study is intended to evaluate the safety and effectiveness of Onyx LES in the treatment of patients with active arterial bleeding in the peripheral vasculature that are deemed suitable for embolisation treatment. In this study, peripheral vasculature is defined as outside of the brain and heart.
“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,” said Stark. “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.”
This pivotal, prospective, multicentre, non-randomised, single-arm study will enrol up to 119 patients from up to 25 sites in the USA. The primary safety and efficacy endpoints will be evaluated through 30 days following treatment with Onyx LES.
“Onyx LES is available with a peripheral indication in many markets outside the USA,” said David Moeller, president of the Peripheral Vascular Health business, which is part of the Cardiovascular Portfolio at Medtronic. “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.”
Medtronic shares that the PELE IDE clinical study will build upon extensive commercial experience from the use of Onyx LES in the peripheral vasculature globally. It aims to provide the necessary evidence to add Onyx LES to the US portfolio of peripheral vasculature embolisation products from Medtronic. The company advises that, in the USA, the use of Onyx LES for embolisation of arterial haemorrhage in the peripheral vasculature is investigational and has not been approved or cleared by the US Food and Drug Administration (FDA).
