Medinol, a company based in Tel Aviv, Israel, has announced that its EluNIR drug eluting stent received the CE Mark of approval in Europe. The device is coated with ridaforolimus to help prevent restenosis and is designed be both highly flexible while maintaining flexibility, making it easier to reach and penetrate difficult lesions.
The company’s Flexx² tip has a tapered spring that keeps the catheter moving through curvy vasculature and prevents flare out and buckling. The so-called WiZeCell strut design uses minimal metal material to support the vessel while preventing vessel tissue from protruding between the struts. The elastomeric coating resists cracking and peeling, releasing ridaforolimus at a steady rate to ensure consistent prevention of restenosis.
The device can be delivered through an endoprosthesis into a side branch, extending its applicability, and includes radiopaque markers for accurate final placement at the target lesion.
Here’s a bit of detail about the two studies that led to the approval, according to Medinol:
In BIONICS, a more-comers study conducted in the United States, Canada, Europe and Israel, EluNIR showed outstanding results including a 12 month TLF rate of 5.4% and 0% Late Stent Thrombosis (n=958), and was non-inferior to the Resolute Zotarolimus eluting stent. In NIREUS, a study conducted in Europe and in Israel, EluNIR demonstrated unprecedented results with an in-stent Late Loss of 0.04mm at 6 months (n=201).
Here’s a short promo video showing off the features of the EluNIR:
Product page: EluNIR…