MFDS Expands Treatment for Cerebral Venous Diseases... Promotes Supply of 'Vascular Occlusion Catheters'
Newly Designated Medical Device Suitable for Cerebral Venous Occlusion Use
Expected to Reduce Surgical Risk
Rare and Urgently Needed for Introduction
The Ministry of Food and Drug Safety announced on the 19th that it has newly designated the intravascular occluding catheter for veins, used in the treatment of dural arteriovenous fistula, as a scarce and urgently needed medical device.
'Dural arteriovenous fistula' is a cerebrovascular malformation in which the cerebral arteries and veins are abnormally connected in the dura mater, the outermost layer of the meninges, causing cerebral edema and cerebral hemorrhage.
The product that the Ministry of Food and Drug Safety plans to newly supply is designed to insert a catheter into the abnormally connected cerebral venous vessels, inflate a balloon to temporarily block the vessel, and enable treatment.
Until now, there has been no product approved domestically for the purpose of cerebral venous occlusion, so catheters approved for arterial occlusion have been used as substitutes. This designation is expected to help expand treatment opportunities for patients with dural arteriovenous fistula.
Ryu Chang-woo, Policy Director of the Korean Society of Neurointerventional Treatment, who applied for the designation of this intravascular occluding catheter for veins as a scarce and urgently needed medical device, stated, "If this product is introduced domestically, it will be possible to use a product suitable for the treatment of dural arteriovenous fistula patients, enabling safer surgeries."
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The newly designated medical device will undergo review by the 'Scarce and Urgently Needed Medical Device Review Committee,' consultation with related academic societies (Korean Society of Cerebrovascular Intervention), and coordination with relevant government departments. Supply applications are expected to be accepted from early February this year. When patients apply for supply, delivery is possible within 1 to 3 months depending on customs clearance and other circumstances.
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