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Pre-clinical experience

The literature is rich with data referring to the benefits of titanium and titanium oxides used for medical applications such as implantable medical devices.


Simpson et al. (*)

reported in a study involving implants made of stainless steel, cobalt and titanium, that clinical symptoms of pain, swelling and inflammation were observed with the first two metals but none with titanium.

 

Steinmann et al. (*)

reported that tissue impregnation by corrosive products is equivalent to a chemical insult, and that metal ions can unite with protein to form an antigen. Such complex formations are known to occur with nickel, cobalt and chromium but are absent from titanium.

 

Irena Gotman (*)

reported that local tissue response to metal implants is closely related to the amount and toxicity of the corrosive products. Thus minimal fibrosis is typically observed around titanium alloys, whereas fibrous layers as much as 2 mm thick are encountered with Co-Cr and especially with 316L stainless steel implants.

 

Zhang et al. (*)

published the results about titanium oxides in vitro examinations showing that titanium oxides were able to inhibit platelet aggregation and fibrin growth.

 

Koster et al. (*)

demonstrated in 2000 that stent induced inflammation could trigger restenosis, therefore a material acting like an unbreakable barrier against the release of toxic ions could have an effect on inflammation and therefore on restenosis reduction.

 

Windecker et al. (*)

demonstrated the efficacy of the Titanium Nitride Oxide compound, showing a neointimal hyperplasia reduction close to 50% compared with 316L stainless steel of identical design in the porcine model at six weeks follow-up. The antiproliferative effect was comparable to that reported by Suzuki* for sirolimus-eluting stents in pigs.

 

product1  Bio Active Stent demonstrating reduced neointimal proliferation.

 

 

 

 

 

 

 

 

product2

 Bare Metal Stent (Control) showing neointimal proliferation.

 

 

 

 

 

 

 

 

 

(*) Clinical data on file at Hexacath.

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