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BOSTON and TEL AVIV, Israel, May 16, 2013 /PRNewswire/ --
InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in embolic protection stents, today announced that it received reimbursement approval for the MGuard™ Coronary Embolic Protection Stent (EPS) from UNIMED, Brazil’s largest private health care insurer.
Alan Milinazzo, InspireMD’s President and CEO said, “Reimbursement in Brazil is a significant achievement that should enable us to expand our presence globally and further penetrate this important market of over 195 million citizens. We are pleased that UNIMED is recognizing MGuard’s clinical value in preventing unstable plaque and clots from breaking away and causing further trauma in acute heart attack patients.”
According to the Brazilian Society of Interventional Cardiology (SBHCI), of the approximately 30,000 Brazilians treated for acute heart attacks each year, roughly one-third experience ST-segment elevation on ECG (STEMI) and require Primary PCI.
“This is the first step in a process that is expected to eventually enable doctors to treat patients with acute coronary syndromes, particularly those with acute myocardial infarction who may be at a high risk of distal embolization, with this innovative EPS system that has shown improved procedural outcomes,” said Prof. Dr. Alexandre A. Abizaid, Director of Interventional Cardiology at Institute Dante Pazzanese in São Paulo, Brazil.
UNIMED is the largest cooperative medical system both in Brazil and globally, providing private health insurance to more than 18 million Brazilians. With 38% of the Brazilian health plan market, UNIMED has more than 109,000 physicians and 3,097 hospitals in its network, according to Brazil’s National Health Insurance Agency (ANS).
About Stenting and MGuard™ EPS
Standard stents were not engineered for heart attack patients. They were designed for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack patient.
In acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted, causing downstream blockages (some of which can be fatal) in a significant portion of heart attack patients.
The MGuard EPS is integrated with a precisely engineered micro net mesh to prevent the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off.
While offering superior performance relative to standard stents in STEMI patients with regard to ST segment resolution, the MGuard EPS requires no change in current physician practice - an important factor in promoting acceptance and general use in time-critical emergency settings.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MGuard technology to make its products the industry standard for embolic protection stents and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.
InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.
MGuard EPS is CE Mark approved. It is not approved for sale in the U.S. by the U.S. Food and Drug Administration (FDA) at this time.
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