InspireMD has announced it has signed Diverse Devices as its exclusive distributor for Australia and New Zealand, and has signed Do Gia Production and Trading JSC as its exclusive distributor in Vietnam. The company’s product line includes the Cguard embolic prevention system (EPS).
Agustin Gago, executive vice president and chief commercial officer of InspireMD, commented: “We are pleased to announce these two additional distributors in the Pacific Rim, which represents the continuation of our planned expansion into the Asian market and further expand our global distribution footprint. Our partners have strong physician networks across all the relevant clinical specialties that treat carotid artery disease in their respective regions. These agreements follow similar announcements in Hong Kong and Taiwan. The Asia-Pacific region represents a sizable and important market given the prevalence of carotid stenting as a preferred alternative to vascular surgery. We look forward to announcing additional partnerships for the region in the coming months.”
The company previously announced the start of patient enrolment in an investigator initiated trial in Russia, seeking to assess the neuro protection and clinical superiority of the minimally invasive interventional procedure with the Cguard EPS vs. Abbott’s RX Acculink carotid stent in patients at high risk for carotid endarterectomy (CEA).
The trial is a single centre randomised trial with two interventional arms comparing Cguard EPS to Acculink. The trial will enroll 100 consecutive eligible patients with 50 patients in each arm. The primary endpoint of the trial will be new ischaemic areas in the brain within 24 to 48hrs post procedure, and new lesion permanence at 30-days as determined by diffusion-weighted magnetic resonance imaging (DWMRI). Each patient will receive clinical and ultrasound follow-up at one year.
The research will be lead by Andrei Karpenko, the head of the vascular surgery department, Center of Vascular and Hybrid Surgery within the Scientific Research Institute of Circulation Pathology in Novosibirsk, associated with Novosibirsk State University.