Sixteen stainless steel and sixteen cobalt-chromium stents were subjected to 40 million cardiovascular cycles representing over one year of implantation life
Enduratec Testing Services, a provider of test services for the medical device industry, announces that it has successfully completed an essential fatigue life test of MIV Therapeutics's proprietary hydroxyapatite (HAp) stent coating.
The test, titled 'In-vitro 40 million cycle accelerated fatigue test for stents with MIV Therapeutics's HAp coating', was conducted to evaluate the mechanical integrity and bonding properties of MIVT's ultra-thin biocompatible coating.
Enduratec summarised: "Sixteen stainless steel and sixteen cobalt-chromium stents, all coated with MIVT proprietary HAp coating, were subjected to 40 million cardiovascular cycles representing over one year of implantation life at an average of 72 heartbeats per minute.
"There were zero failures of the stent structure detected by Enduratec during visual inspection which included evaluation of the general condition of both the tested stainless steel and cobalt-chromium stents coated with HAp".
Tom Troczynski, MIVT's vice president of coatings, commented, "Enduratec's test results confirm our preliminary assessment of the bonding properties of our HAp coating.
"Subsequent analysis of the filters at UBC showed no evidence of hydroxyapatite particles. "These results are extremely rewarding and validate our earlier expectations regarding the durability of our ultra-thin coating".
MIVT President and CEO Alan Lindsay adds: "The critical path of our R and D programME has passed another essential milestone.
"Our HAp coating had previously successfully completed a critical thrombogenicity animal trial where it was exposed to blood-flow and showed no signs of toxicity or thrombosis (blood-clotting).
"This test with Enduratec Testing Services now shows that the coating is able to withstand the rigorous demands of the circulatory system over time.
"This fatigue life test is a cornerstone of a comprehensive range of mechanical and animal testing required for the successful commercialisation of our proprietary HAp coating technology".
