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Members of the Korea Congenital Heart Disease Patient Group (CHD) began a campaign in May 2017 demanding that Gore continues to supply artificial blood vessels to the South Korean market. Gore withdrew from the South Korean market in September 2017. (provided by CHD)

Amid growing fears that South Korean hospitals may soon run out of the artificial blood vessels needed for surgery on pediatric heart disease patients, government public health officials have decided to visit the headquarters of vascular graft producer Gore to actively request that it resume its operations in South Korea.

The Korea Congenital Heart Disease Patient Group (CHD Korea) is also awaiting a response from Gore after sending a list on Mar. 8 of items that need to be supplied. Observers are now watching for a forward-looking response from Gore, which previously withdrew its medical project division from the South Korean market in Oct. 2017.

“We plan to pay an emergency visit to Gore’s offices in the US to explain about the difficulties currently being experienced by South Korean pediatric heart disease patients and the improvements that have been made in the medical component pricing system and to request that Gore actively consider resuming supplies in South Korea,” relevant agencies including the Ministry of Food and Drug Safety (MFDS) and Ministry of Health and Welfare (MOHW) said in a statement on Mar. 10. The date of the visit is currently being discussed with Gore.

“We are trying to meet as soon as possible, and we intend to work to actively accept the conditions named by Gore to ensure no setbacks in domestic supplies of vascular grafts,” an MFDS official said.

Famous for its Gore-Tex material, Gore has a medical product division that produces and sells medical components including vascular grafts (artificial blood vessels). In South Korea, supplies of polytetrafluoroethylene (PTFE) vascular grafts measuring over 10mm – used chiefly for the Fontan procedure, a form of heart surgery performed on children suffering congenital heart ailments – have been discontinued, resulting in major hospitals having to indefinitely postpone scheduled procedures for pediatric patients since last month. The components hurriedly stockpiled by hospitals when Gore pulled out in 2017 have recently come close to running out.

In a Mar. 8 email to MFDS, Gore explained that vascular grafts measuring over 10mm did not need to be supplied because alternative products from other companies are available in South Korea. The message came in response to the ministry’s request last month that the company resume supplies of vascular grafts and suture materials needed for pediatric heart surgery.

A ministry official said, “The part about ‘alternative vascular grafts being available in South Korea’ was a misunderstanding on Gore’s part, and we plan to visit in person to explain that.” Fortunately, Gore did reply that it plans to resume supplies of suture materials, for which no alternative products exist.

According to experts, Gore’s departure in 2017 left domestic importers with rights to supply vascular grafts with diameters of 3.5mm, 4mm, and 5mm. The grafts are used in primary surgeries for children born with congenital heart deformities. The vascular grafts over 10mm that have recently become an issue are used in a tertiary operation known as the Fontan procedure. In 2016, a total of 130 grafts measuring 3.5–5mm and 52 grafts measuring over 10mm were used in operations in South Korea. The small quantities and large varieties produced meant the items were not especially profitable for the company.

While Gore claimed that alternative products already exist in South Korea for the grafts over 10mm, CHD Korea and others said no alternatives to the Gore products exist. While there are other products with diameters of 10mm or more, they are not usable because they employ different materials, they explained.

An official with MOHW’s insurance payment division explained, “What cardiothoracic surgeons are saying is that when other substitute items are used in operations, the vessels frequently become clogged and additional surgery is required, so there is effectively no alternative.”

“At the time Gore withdrew from the South Korean market, it pledged to continue supplying products for which no alternatives were available,” the official added.

In Sept. 2018, MOHW cleared the way for Gore to resume supplies by issuing an amended announcement allowing the health insurance charge ceiling to be increased for treatment materials for pediatric patients and rare conditions with no alternatives available, which it now assesses as “rare/essential treatment materials.”

On Mar. 8, CHD Korea contacted Gore to send a list of items needed for surgery. It is currently awaiting a reply.

“Gore agreed to send a response once it has reviewed the list of items for resumed supply,” said CHD Korea representative Ahn Sang-ho.

By Hwang Ye-rang, staff reporter

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