Korean health officials said they would soon visit the headquarters of W.L. Gore in the U.S. to help supply the company’s artificial blood vessels for Korean children with heart conditions.
Gore was the sole provider of artificial blood vessels for the surgery of pediatric patients with congenital complex heart malformations, but the company withdrew from Korea in October 2017.
As the decision threatened the lives of children born with heart problems, medical societies and patient groups have steadily demanded the government address the supply shortage.
On Feb. 8, the government requested Gore to resume the supply of artificial blood vessels and suture threads for the Korean market. After a month, however, the company replied that it could supply sutures, which do not have a replacement in Korea, but not artificial vessels “because there were other substitutes in Korea.”
However, the Korean Society for Thoracic and Cardiovascular Surgery (KSTCVS) noted that artificial blood vessels used in the pediatric cardiac surgery, known as the Fontan procedure, had no alternative to Gore’s products.
The Fontan procedure is a general term for right atrium-pulmonary artery bypass surgery. Artificial blood vessels of polytetrafluoroethylene (PTFE) thicker than 10mm, solely manufactured by Gore, are mostly used in the Fontan procedure. Surgeons cannot use other products with the same diameter because they were made of different materials, the KSTCVS said.
Officials from the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, and the Health Insurance Review and Assessment Service will make an urgent visit to Gore’s headquarters to explain what Korean children patients with heart problems are going through.
They will also illustrate how the Korean pricing system for treatment materials improved and appeal for a resumption of supplies for the Korean market.
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