Globe Newswire06.04.18
InspireMD Inc., a leader in embolic prevention systems (EPS)/thrombus management technologies and neurovascular devices, has received regulatory approval, and has initiated commercialization of its CGuard Embolic Prevention System (EPS) and MGuard Prime in Vietnam. Both of these devices utilize the company's patented MicroNet technology.
"Our ability to initiate commercialization for both of the company’s devices was due to our capability to coordinate getting three key elements in place concurrently and quickly. Specifically, we secured regulatory approval, a valid import license and product reimbursement, all of which come from Vietnam’s Department of Medical Equipment and Health Works (DMEHW), a unit of the Ministry of Health (MOH).
Part of this effort was coordinated by DO GIA, our recently appointed distributor in Vietnam. DO GIA has an established distribution network across Vietnam that covers both physicians, clinics and hospitals. With a population of over 100 million people, Vietnam represents another important step forward in our focused expansion across Asia," commented Agustin Gago, chief commercial officer of InspireMD.
CGuard EPS is a carotid embolic protection system that is designed to deliver the company’s self-expanding stent wrapped in the company’s proprietary MicroNet technology to the carotid arteries using a rapid exchange delivery system to prevent embolic events that can lead to stroke. The MGuard Prime coronary stent system consists of the company’s coronary balloon expandable stent wrapped with MicroNet pre-mounted on a rapid exchange balloon catheter, that prevents embolic events in the heart that can result in myocardial infarction, heart failure and even death. Both products are now being sold in a variety of markets across Europe, Middle East, Asia and Latin America.
InspireMD seeks to utilize its proprietary MicroNet technology to make its products the industry standard for embolic protection 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 MicroNet technology in coronary, carotid (CGuard), neurovascular, and peripheral artery procedures.
"Our ability to initiate commercialization for both of the company’s devices was due to our capability to coordinate getting three key elements in place concurrently and quickly. Specifically, we secured regulatory approval, a valid import license and product reimbursement, all of which come from Vietnam’s Department of Medical Equipment and Health Works (DMEHW), a unit of the Ministry of Health (MOH).
Part of this effort was coordinated by DO GIA, our recently appointed distributor in Vietnam. DO GIA has an established distribution network across Vietnam that covers both physicians, clinics and hospitals. With a population of over 100 million people, Vietnam represents another important step forward in our focused expansion across Asia," commented Agustin Gago, chief commercial officer of InspireMD.
CGuard EPS is a carotid embolic protection system that is designed to deliver the company’s self-expanding stent wrapped in the company’s proprietary MicroNet technology to the carotid arteries using a rapid exchange delivery system to prevent embolic events that can lead to stroke. The MGuard Prime coronary stent system consists of the company’s coronary balloon expandable stent wrapped with MicroNet pre-mounted on a rapid exchange balloon catheter, that prevents embolic events in the heart that can result in myocardial infarction, heart failure and even death. Both products are now being sold in a variety of markets across Europe, Middle East, Asia and Latin America.
InspireMD seeks to utilize its proprietary MicroNet technology to make its products the industry standard for embolic protection 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 MicroNet technology in coronary, carotid (CGuard), neurovascular, and peripheral artery procedures.