MFDS Designates Catheter for Aortic Valve Procedures as a Rare Medical Device

The Ministry of Food and Drug Safety announced on the 6th that it has designated one product, the 'Balloon Expandable Valve Shaping Catheter' used for artificial valve insertion during aortic valve replacement procedures, as a rare medical device.

Balloon-expandable valve molding catheter. [Photo by Ministry of Food and Drug Safety]

Rare medical devices are those used for diseases with a small number of patients domestically and have special utility value for their intended use. They are designated when they are used for the treatment or diagnosis of rare diseases with fewer than 20,000 patients (prevalent population) in Korea, or when there is no appropriate treatment or diagnostic method available domestically, or when they are recognized to have special utility value for their intended use.

The newly designated product is used during procedures to insert an aortic valve without thoracotomy or open-heart surgery, to pre-expand a calcified aortic valve or to install and subsequently expand an artificial valve at the affected site. Currently, about 1,000 patients annually undergo transcatheter aortic valve replacement in Korea, and among them, about 200 require the use of the balloon expandable valve shaping catheter due to severe valve stenosis.

Through the designation as a rare medical device, this product will be subject to expedited review with a 50% reduction in the statutory processing period, and even with limited clinical cases, the data will be accepted as approval review materials, enabling faster approval.

Professor Bae Jang-hwan of the Department of Cardiology at Chungbuk National University Hospital said, "Aortic valve stenosis is a severe disease requiring surgical valve replacement or transcatheter aortic valve implantation, and using this catheter during surgery for patients with severely stenotic valves is expected to allow safer and easier insertion of the aortic valve," adding, "We welcome the designation of this product as a rare medical device."

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