InspireMD receives approval to commercialize CGuardTM

Embolic prevention leader InspireMD Inc. received regulatory approval Monday to commercialize the CGuardTM Embolic Prevention System (EPS) for the treatment of carotid artery disease in Argentina.

The CGuard EPS prevents peri-procedural and late embolization by trapping potential emboli against the arterial wall.

“We are pleased with the approval of CGuardTM in Argentina, adding a second key market to our Latin American footprint following our approval in Colombia in early October,” Alan Milinazzo, CEO of InspireMD, said.

The Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) granted the approval.

The global carotid stent market is estimated to grow at a compound average annual rate of 13 percent between 2014 and 2019, while the Latin American carotid stent market is also expected to grow aggressively due to endovascular procedure volume growth and the adoption of premium priced products, according to the Millenium Research Group.

“With CGuardTM, we offer an enhanced minimally invasive solution to carotid artery disease treatment, supported by positive clinical experience," Milinazzao said. "Last week, at Transcatheter Cardiovascular Therapeutics (TCT), the largest educational meeting in interventional cardiovascular medicine, clinical data on CGuardTM was presented at carotid scientific sessions, with very positive physician feedback."