MITECH, Two Types of Esophageal Stents Approved by US FDA

[Asia Economy Reporter Hyunseok Yoo] MI Tech, a manufacturer of non-vascular stents, announced on the 26th that it has obtained FDA approval for two types of esophageal stent products from the U.S. Food and Drug Administration (FDA).

Including this approval, MI Tech has secured FDA approval for a total of 12 gastrointestinal stent products (3 types for bile ducts, 6 types for the esophagus, 1 type for the colon, 1 type for the duodenum, and 1 type for the trachea and bronchi).

The approved products are two types of Hanaro Stent esophageal products, available in fully covered (CCC) and partially covered (NCN) forms, used to relieve esophageal strictures caused by malignant tumors and to occlude esophageal fistulas. Unlike the existing partially covered esophageal stents that use the TTS (Through The Scope) procedure, these use the OTW (Over The Wire) procedure to alleviate strictures, which is a distinctive feature.

The company expects that with this FDA approval, the product lineup of its flagship esophageal stents will expand, broadening user choices and enabling application to various cases.

A company representative stated, “Through this FDA product approval, we anticipate strengthening our competitiveness in the U.S. market and expanding our market share. We will continue steady research and development and marketing activities to achieve both global market growth and solid performance growth.”

Meanwhile, MI Tech is one of the key companies in the Synergy Partners Group and is a KOSDAQ-listed company specializing in the manufacture of non-vascular stents.