Israel-based cardiovascular medical devices maker Medinol has completed the first-in-human implantation of its ChampioNIR Drug-Eluting Peripheral Stent.
The first-in-human implantations were carried out by surgeons Dr Gerard Goh and Dr Thodur Vasudevan of the Alfred Hospital in Melbourne Australia.
The ChampioNIR stent system combines a highly deliverable, and virtually un-fracturable stent that delivers the drug to every millimetre of the vessel surface.
It comes with a self-expanding nitinol radial structure for enhanced flexibility and fracture resistance, and polymeric coating for tensile strength for precise implantation and drug delivery.
The Alfred Hospital interventional radiology head Gerard Goh said: “We were impressed with ChampioNIR’s deliverability and its straightforward deployment. The Frictionless Deployment Mechanism made the precise positioning of the stent very straightforward.”
Medinol CEO Dr Yoram Richter said: “Medinol is excited to bring to clinical practice the culmination of years of research and development into novel stent designs, tailor-made for unmet clinical challenges in vascular interventions.”
Medinol said its ChampioNIR drug-eluting peripheral stent system is an advanced technology designed to improve patient outcomes and procedural success.
It comes with a hybrid mechanical design, where the metallic component of the stent provides radial support, and a bioresorbable polymeric mesh provides a longitudinal structure.
The mesh provides enhanced flexibility and long-term durability in challenging anatomies.
Also, the ChampioNIR system features a unique drug-elution mechanism that releases drugs from the cylindrical area of the stent.
Its approach significantly reduces diffusion distances and facilitates the therapeutic dosing of a large peripheral vessel with a ‘limus’ drug for an extended period.
Medinol intends to conduct the CHAMPIONSHIP first-in-human study, which will enrol 30 patients across seven sites in Australia and the US.
CHAMPIONSHIP study PI Sahil Parikh said: “The ChampioNIR stent represents a breakthrough in treatment for SFA lesions. I am excited to see this device come to life after years of development.”
