MicroPort Received CFDA Approval for Newly Extended Specifications of Apollo Intracranial Arterial Stent System
MicroPort NeuroTech is pleased to announce that newly extended specifications for Apollo Intracranial Arterial Stent System recently received official certification of regulatory approval from China Food and Drug Administration (CFDA). Apollo is researched and developed independently by MicroPort NeuroTech (Shanghai) Co., Ltd. ("MicroPort NeuroTech"). There are 13 new general specifications added to the existing 15 specifications. The extended product portfolio provides more selections for physicians and improves the safety and efficacy for the operation.
Apollo Intracranial Arterial Stent System was originally approved by CFDA in 2004, and was the first balloon-expandable intracranial stent for the treatment of brain stroke entirely developed and designed in China. Since its introduction in 2005, Apollo has been well received among the neurologist community and currently has 65% domestic market share.
Apollo stent structure is especially indicated for the anatomic features of intracranial vessels, achieving a perfect combination of radial strength and flexibility. The Rapid Exchange delivery catheter is designed to pass complex tortuous vascularity, presenting excellent trackability and reachability. Since its introduction Apollo has been used for treating brain stoke cases in more than 400 hospitals nationwide, and to date more than 20,000 patients have benefited from our product. Apollo also won second award of Shanghai Scientific and Technological Progress in 2009, and was named Shanghai Key New Product in 2010.
Studies show that 10%-29% of cerebral ischemia are caused by intracranial atherosclerosis, and that each year, between 40,000-60,000 patients in the USA, suffer stroke caused by or related to intracranial artery stenosis, This accounts for about 10%-20% of all stroke patients, and treatment of atherosclerotic intracranial stenosis has become the major preventive measure for ischemic cerebrovascular disease.
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