It is necessary to develop and use medical equipment quickly to match the pace of rapid increase in a cerebral aneurysm, a Korean doctor stressed Thursday.
|Professor Suh Dae-Chul|
Prophylactic treatment of a cerebral aneurysm, caused by the rupture of swollen vessels, is essential. And non-invasive procedures using a stent to block such abnormal cerebral blood vessels with coils have steadily increased recently.
“Innovative devices are being developed very actively worldwide to treat a cerebral aneurysm,” said Professor Suh Dae-Chul of the radiology department at the hospital. “However, the speed with which these innovative devices are introduced in the Korean medical fields is quite slow.”
Treatment options for cerebral aneurysms include a surgical treatment, which clips the bulged cerebral blood vessels and a coil embolization, which prevents an abnormal blood flow by inserting a coil in the blood vessel. In Korea, the number of coil embolization procedures surpassed 6,000 in 2012, as the noninvasive method is used more often than open-surgery.
Professor Seo pointed out that the newly developed devices around the world have shown excellent efficacy in the treatment of intractable aneurysms, and many Korean and foreign patients have benefited from the new equipment.
This notwithstanding, the procedure for approving the new therapeutic device by the Korean government is complicated, and are given only after such devices win approvals in foreign countries, he pointed out.
“Even after the authorization, it takes a considerable amount of time for the medical device manufacturers to supply their products to medical fields,” he added.
For example, the EU approved the pipeline, which is used to expand the stenosis of an aneurysm into the blood vessels around the entrance of an aneurysm, in 2009. However, it took an additional two years for the Ministry of Food and Drug Safety to approve the device. And it took six more years for the ministry to classify the equipment as a new medical technology and receive insurance coverage.
As a result, a medical device that has been in use in the EU since 2009, only became available in Korea in 2015.
“In the treatment of cerebral arteries, where prophylactic treatment is important, innovative devices that enhance the effectiveness and safety of the procedure are being developed,” Seo said. “However, it takes a long time for Korean medical workers to use these devices.”
The regulatory authorities here should implement a process that can quickly introduce well-recognized medical devices abroad so as not to deprive Korean patients of opportunities to treat their diseases, Seo stressed.
The Journal of Stroke published the results of Professor Seo’s study in its recent issue.
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