InspireMD has made its proprietary stent system technology MGuard available in South Africa though its exclusive South African distributor Tau Medical.
The CE mark approved MGuard presents a novel combination of a coronary stent merged with an embolic protection specifically designed for acute myocardial infarction (MI) patients.
The embolic protection is comprised of an ultra-thin polymer mesh sleeve that wraps the stent.
South African Society of Cardiovascular Intervention president and cardiologist Graham Cassel will lead the South African arm of the MGuard MASTER Randomized Trial (MGUARD for Acute ST Elevation Reperfusion).
The trial is a multinational randomized controlled trial designed to demonstrate MGuard Coronary Stent’s superiority over standard care for STEMI (heart attack) patients.
The MASTER Randomized Trial will enroll 432 patients.
The study’s primary endpoint is complete ST segment resolution post procedure.
The trial will be conducted in 10 countries in Europe, South America and South Africa.
InspireMD CEO Ofir Paz said he is confident that Tau Medical is the right partner to optimize MGuard’s success in this lucrative market and to further pursue clinical program to demonstrate MGuard advantage over standard care in STEMI Patients.