Globe Newswire04.03.18
InspireMD Inc., a developer of embolic prevention systems (EPS)/thrombus management technologies and neurovascular devices, announced successful treatment of the first patient in India with CGuard EPS. The case was performed at Shri B. D Mehta Mahavir Hospital in the city of Surat, Gujarat state, by Dr. Hiral Shah, an interventional neuro-radiologist.
This first case in India follows the recently announced exclusive distribution agreement for CGuard EPS with Hester Diagnostics Pvt. Ltd., as well as recent regulatory and marketing clearance granted by India’s Central Drugs Standard Control Organisation within the Ministry of Health & Family Welfare.
Sanjiv Gandhi, managing director of Hester Diagnostics, commented, “The patient in this case had severe stenosis with the carotid artery occluded by more than 80 percent, including blockage of blood flow through the left common carotid artery, and the patient was experiencing transient ischemic attacks. Following the procedure, Dr. Shah reported complete procedural success using CGuard EPS. We are very happy with the product performance, as anticipated, and look forward to rolling out CGuard EPS broadly across India.”
Agustin Gago, EVP and chief commercial officer of InspireMD, commented, “We are extremely pleased by how quickly the first procedure was performed in India following regulatory and marketing clearance and announcing our distribution partnership with Hester Diagnostics. The speed in which this was done not only underscores our distributor capabilities but having CGuard EPS used in India also represents a milestone in our expansion efforts across Asia.”
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.
This first case in India follows the recently announced exclusive distribution agreement for CGuard EPS with Hester Diagnostics Pvt. Ltd., as well as recent regulatory and marketing clearance granted by India’s Central Drugs Standard Control Organisation within the Ministry of Health & Family Welfare.
Sanjiv Gandhi, managing director of Hester Diagnostics, commented, “The patient in this case had severe stenosis with the carotid artery occluded by more than 80 percent, including blockage of blood flow through the left common carotid artery, and the patient was experiencing transient ischemic attacks. Following the procedure, Dr. Shah reported complete procedural success using CGuard EPS. We are very happy with the product performance, as anticipated, and look forward to rolling out CGuard EPS broadly across India.”
Agustin Gago, EVP and chief commercial officer of InspireMD, commented, “We are extremely pleased by how quickly the first procedure was performed in India following regulatory and marketing clearance and announcing our distribution partnership with Hester Diagnostics. The speed in which this was done not only underscores our distributor capabilities but having CGuard EPS used in India also represents a milestone in our expansion efforts across Asia.”
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.