MIV posts positive one-year data on polymer-free DES, with no Plavix for 8 months
MIV Therapeutics, a developer of next-generation coatings and drug-delivery systems for cardiovascular stents, has reported positive safety and efficacy results at 12-month clinical follow up for all 15 patients in its first-in-man (FIM) VESTASYNC I trial of its VESTAsync polymer-free drug-eluting stent.
In addition, data using intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) have now been generated for all 15 patients at nine-month follow-up, which showed no difference from the safety and efficacy data on 11 and 12 patient nine-month data presented at the American College of Cardiology (ACC) conference in March.
“We are very excited that the data from the VESTASYNC I FIM Trial continue to show excellent safety and efficacy, with no major adverse cardiac events for all 15 patients involved. Significantly, at this point all of our patients are Plavix-free, and have been so for at least eight months, which suggests that the VESTAsync drug-eluting stent has the potential to reduce the current treatment paradigm for these patients to short-term anti-coagulant therapy from the current standard of a minimum of one year,” said Mark Landy, MD, MIV president and CEO.
In addition, data using intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) have now been generated for all 15 patients at nine-month follow-up, which showed no difference from the safety and efficacy data on 11 and 12 patient nine-month data presented at the American College of Cardiology (ACC) conference in March.
“We are very excited that the data from the VESTASYNC I FIM Trial continue to show excellent safety and efficacy, with no major adverse cardiac events for all 15 patients involved. Significantly, at this point all of our patients are Plavix-free, and have been so for at least eight months, which suggests that the VESTAsync drug-eluting stent has the potential to reduce the current treatment paradigm for these patients to short-term anti-coagulant therapy from the current standard of a minimum of one year,” said Mark Landy, MD, MIV president and CEO.