InspireMD Gains MGuard Prime Approval in Brazil

InspireMD Gains MGuard Prime Approval in Brazil

Device is CE Mark-approved but not for sale in the United States.

InspireMD’s MGuard Prime with MicroNet technology, a stent embolic protection system, has won regulatory approval in Brazil, the Boston, Mass., devicemaker said.

The device was developed to trap and seal thrombus and raptured plaque, prevent distal embolization and maximize flow in segment elevation myocardial infarction patients, executives noted in a news release.

Brazil, with a rapidly aging population, growing economy and improving healthcare system that is boosting the number of coronary stent procedures, has the largest coronary stent market in Latin America, CEO Alan Milinazzo said. The Brazil, Russia, India, China, South Africa and South Korea coronary stents sector is projected to reach $1 billion by 2016, growing at an average compound annual rate of 9.6 percent through 2018, according to Research and Markets.

“Brazil is the largest Latin American coronary stent market with a rapidly aging population, growing economy, and improving healthcare system, fueling coronary stenting procedure volumes.” Milinazzo said. “Approval of MGuard Prime is significant as we look to return to revenue growth as Brazil has traditionally been a very strong market for us with support from a number of leading interventional cardiologists around the country.”

The device is CE Mark-approved but is not authorized for sale in the U.S.“I am gratified that MGuard Prime is now approved and available to treat STEMI patients in Brazil. Clinical trials and registry studies have provided a substantial body of evidence supporting the use of MGuard in primary PCI with the objective of improving patient outcomes. With MGuard Prime, the treatment of acute MI has reached a new level involving a simple device that can be used in daily practice in the cardiac cath laboratory,” Alex Abizaid, M.D., chief of Coronary Interventions at Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil, added.

InspireMD developed and commercializes its MicroNet stent platform technology for the treatment of complex coronary and vascular disease.

Watch an MGuard Prime case study video from InspireMD below:

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