CGuard Embolic Prevention System (EPS) (InspireMD) has been granted regulatory approval by the Therapeutic Goods Administration (part of the Australian Government’s Department of Health) for commercial sale and reimbursement in Australia.
The launch of the CGuard (EPS) will commence immediately in collaboration with InspireMD’s local distributor partner, Diverse Devices, of Sydney, Australia.
“Australia’s Therapeutic Goods Administration sets a high bar in terms of regulatory and reimbursement approval of new medical devices. We believe our approval reflects not only the agency’s recognition of CGuard’s differentiating features versus conventional carotid stents, but also the need for safer treatments for carotid artery disease. We are eager to begin offering this novel technology to patients in Australia imminently,” said James Barry, chief executive officer of InspireMD.
Aidan McEvoy, director of Diverse Devices, commented, “At Diverse Devices, we strive to bring the latest technologies to health care professionals across Australia, and we are pleased to add CGuard EPS to our portfolio of the most innovative stent products available on the market today.”