STENTYS Self-Apposing Stents
The STENTYS Self-Apposing® stents represent a major breakthrough: they solve the stent sizing dilemma that cardiologists are confronted with when a vessel size is ambiguous or challenging.
In a STEMI patient where vasoconstriction and thrombus obscure the native vessel diameter, the STENTYS stent mimics the shape and diameter of the natural artery to achieve perfect apposition, and adapts to anatomic changes during the post-AMI phase to maintain apposition.
Likewise in a tapered vessel such as a bifurcation lesion, the STENTYS stent is able to adapt itself to the varying proximal and distal diameters of the vessel in order to ensure stent apposition all along the vessel wall, without the need for complex balloon techniques or kissing.
The STENTYS technology consists of a unique, self-expanding stent platform that has been designed and tested to address the challenges of treating coronary arteries with ambiguous vessel diameters or with areas of vessel diameter fluctuations and/or large side branches. It is built out of Nitinol, a titanium alloy with super-elastic properties.
The stent’s short, expandable segments and its self-expansion feature allow for excellent vessel conformability as well as continuous apposition along the arterial wall, superior to existing balloon-expandable stents as demonstrated through OCT imaging in the APPOSITION II study.
The gentle expansion forces are well-suited for deployment in an artery with a heavy clot burden, like in acute settings.
The STENTYS stent is designed with small distinctive interconnectors that can be used to create an opening through the stent. It allows the physician to safely navigate and deploy the stent, then disconnect the stent interconnectors with an angioplasty balloon to provide side-branch access independent of the side-branch ostium location. The interconnectors are placed all along the length and the circumference of the stent, apart from the first and last 2mm.
The STENTYS stents are available in small (2.5-3.0mm), medium (3.0-3.5mm) and large (3.5-4.5mm) and in lengths 17mm, 22mm, 27mm and 37mm.
The large size STENTYS stent (indicated for vessels from 3.5-4.5mm) can expand to over 6mm in case of positive remodelling of the vessel.
The STENTYS Xposition S has a biostable, polysulphone polymer which elutes Sirolimus. The proprietary polymer blend carrier has no pharmaceutical action and is composed of Polysulphone (PSU) and soluble Polyvinylpyrrolidone (PVP) as an excipient for the polymer blend coating formulation.
Polysulphone has shown proven hemocompatibility for almost four decades in millions of hemodialysis patients, as it is used to coat dialysis devices: in the wet state a hydrogel is formed on the surface of the polymer making it extremely hydrophilic and hemocompatible.