MFDS designates 'Saengchejaejil artificial heart valve' as a rare and urgently imported medical device

The Ministry of Food and Drug Safety announced on the 30th that it has newly designated the 'biological artificial heart valve,' necessary for surgery in patients with heart disease, as a rare and urgently needed medical device.

Biomaterial artificial heart valve. [Photo by Ministry of Food and Drug Safety]

The newly designated product is the 'KONECT RESILIA aortic valved conduit' from Edwards Lifesciences in the United States. It is used in surgeries that replace the aortic aneurysm and aortic dissection areas with an artificial valve and blood vessel, and it is a product combining a valve (biological material) and a blood vessel.

This product has the advantage of reducing surgery time and lowering surgical risk compared to directly connecting and transplanting separate artificial valve and blood vessel products. Additionally, since it is a biological material valve, there is no need for long-term anticoagulant medication, preventing related side effects.

Patients and medical institutions can apply for product supply starting next month, and depending on customs clearance, the product will be supplied to medical sites within about a month. The Ministry of Food and Drug Safety expects that approximately 30 heart disease patients will benefit from treatment annually.

Professor Kim Kyunghwan of the Department of Cardiovascular and Thoracic Surgery at Seoul National University Hospital said, "With this new designation, safe and efficient surgery tailored to the patient's condition and circumstances is possible, and postoperative prognosis will improve, contributing to the enhancement of patients' quality of life."

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