MITECH, Esophageal Stent Approved by US FDA

[Asia Economy Reporter Hyunseok Yoo] MI Tech, a manufacturer of non-vascular stents, announced on the 19th that it has received FDA approval for its esophageal stent product.

Including this recent approval, MI Tech has obtained FDA approvals for a total of 13 types of gastrointestinal stent products (3 types for bile ducts, 7 types for esophagus, 1 type for colon, 1 type for duodenum, and 1 type for trachea/bronchi).

The newly approved product is the Hanaro Stent esophageal product, used to alleviate esophageal stricture and esophageal fistula closure caused by malignant tumors. This product is fully covered and designed with a dumbbell structure featuring asymmetric heads. Generally, the heads are located at both ends of the stent to prevent migration within the body; however, when inserted into the upper esophagus, the head may touch the pharynx (throat), causing discomfort to the patient. Compared to the company’s existing esophageal stents, the Hanaro Stent esophageal product has a shorter head on one side, minimizing the foreign body sensation experienced by patients.

With this FDA approval, the product lineup in the largest market worldwide, the United States, has expanded, broadening users’ product choices and enabling application to various cases. It is expected that the market share of the esophageal product group will increase. Furthermore, this is anticipated to strengthen global competitiveness, and the company plans to steadily continue both external growth and internal stability.

A company representative explained, “Despite the recent COVID-19 situation, the company has continuously maintained sales growth, and through this FDA approval, we will sustain growth momentum and lead qualitative and quantitative expansion.”

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

This content was produced with the assistance of AI translation services.