Metal Implant Coating Significantly Reduces Body's Reaction to Foreign Objects

Any medical device introduced into the bloodstream triggers what's known as a thrombo-inflammatory response. This activates the blood clotting system, which could potentially lead to thrombosis, or blood clots. Stents, which are metal nets used to unblock blood vessels, are particularly prone to this issue. When a stent activates the coagulation system and a clot forms within it, the consequences can be severe, even fatal. Now, a noble metal coating for implant materials has been shown to reduce thrombo-inflammatory reactions and acute stent thrombosis, significantly lowering the body's response to foreign objects.

Bactiguard Holding’s (Tullinge, Sweden) has developed a noble metal coating that inhibits microbial adherence to the surface of medical devices. Previous research indicated that this coating might also reduce thrombo-inflammatory reactions. The current study aimed to gather more conclusive evidence on the coating's effectiveness in preventing these reactions as well as acute stent thrombosis. For this study, two versions of the coating were tested on stents: Bactiguard's standard coating of gold, silver, and palladium, and a modified version incorporating neodymium. A variety of research techniques were used, including in vivo tests on pigs and in vitro blood marker analysis involving human samples. The pigs were implanted with both coated and non-coated stents, with the interventionist unaware of the coating status of the stents.

The study was concluded after two hours, representing the acute phase of the implantation. The stents were inserted into the lingual artery, with one coated and one uncoated on each side. A CT scan was then used to analyze the volume of the stents, with the assessment being conducted by an individual blinded to the treatment details. Additional lab tests were conducted using both human and pig blood, with informed consent obtained from all human participants. The results indicated that the stents with the coating had a significant reduction in clot volume compared to the uncoated stents. This was noticeable as early as one hour post-implantation and became even more evident at the two-hour mark. Laboratory data also demonstrated a considerable drop in markers for coagulation and inflammation in the coated stents relative to the control group.

"The finding of this study is promising and yet another set of important data supporting the efficacy of Bactiguard's coating,” said Stefan Grass, Chief Medical Officer at Bactiguard. “The combination of infection prevention without increased risk of thrombosis is very appealing and unique for a coated intravascular device."

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