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Technology and device description

A proprietary process has been developed to coat Titanium Nitride Oxide on the stent surface based on a plasma technology using the nanosynthesis of gas and metal.

 


 

First, a custom-made chamber forms a vacuum with the help of cryogenic pumps working at – 200°C.

Pure titanium (99.99%) is used to obtain a titanium atomic vaporisation further to the injection of noble gas. The combination of magnetic fields, vacuum and simultaneous injections of nitrogen and oxygen are necessary to create ionisation and a plasma formation of Titanium Nitride Oxide. Plasma is considered to be the 4th state of the matter after liquid, solid and gas. Titanium Nitride Oxide is then coated on all the surfaces of the stent both inside and outside, through a unique and patented Hexacath process which results in NO-particles presence on the stent surface (*). This coating is extremely dense and hard, making Titanium Nitride Oxide coated stents extremely well adapted for direct stenting where the most calcified lesions cannot damage at all the external layers of the coating.

 

However, the biggest challenge was to develop a process where the coating, which is comparable to a ceramic, would adhere homogeneously to the stainless steel or Cobalt-Chromium substrates without any fracture after the stent expansion. Fatigue tests simulating 10 years of stent implantation with scanning electron microscope analysis have proven the integrity of the Hexacath Titanium Nitride Oxide coating. This coating has been shown to remain intact after stent implantation without any sign of micro fractures, thus ensuring the bio active coating benefits, which is specifically active against both restenosis and thrombosis, as well as being an accelerator of reendothelialisation.

 

Titan Optimax is the 3rd Bio Active Stent generation laser cut in a slotted tube, made of medical grade cobalt chromium alloy and coated with a thin atomic layer of Titanium Nitride Oxide.

The stent is mounted on a Hexacath 140 cm long PTCA balloon carrier, rapid exchange, compatible with 0.014” guidewires and made of semi-compliant balloon material. The catheter benefits from a hydrophilic coating and its shaft characteristics enable kissing balloon procedures in 6Fr guiding catheters.

 

The stent platform is the bare metal stent Helix benefiting from a unique double helicoidal design providing excellent flexibility, conformability as well as high radial force.

In addition, the new cobalt-chromium alloy is denser and allows the use of thinner struts. These features result in optimised stent navigation inside the curved arteries and minimal stent induced trauma and inflammation due to this highly conformable helicoidal structure. The unique design of Titan Optimax stent provides also ultra-low recoil and shortening.

This platform enables also the treatment of lesions located in bifurcations and gives an easier side branch access. Titan Optimax is available in various diameters and lengths and provides an “Extra Small” and “Extra Large” design with a stent strut thickness adapted to each vessel diameter starting at 60 microns.

 

 

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