Medtronic Korea Obtains Domestic Approval for Next-Generation Coronary Treatment Catheter 'Prevail'

Medtronic's drug-coated balloon catheter 'Prevail'
Photo by Medtronic Korea

[Asia Economy Reporter Lee Gwan-joo] Medtronic Korea, the Korean branch of Medtronic, announced on the 7th that it has obtained approval from the Ministry of Food and Drug Safety for the drug-coated balloon catheter 'Prevail™'.

With this approval, Medtronic Korea has expanded its portfolio for use in domestic coronary interventions, adding to the drug-eluting stent 'Resolute Onyx™' and the balloon expansion catheter 'Euphora™'.

Angioplasty using drug-coated balloons is a method of treating coronary artery stenosis or occlusion by inserting a balloon coated with medication into the arterial lesion, inflating it to compress atherosclerotic plaques against the vessel wall, and delivering and absorbing the drug. Since permanent device implantation is not required, it is used when drug-eluting stent insertion is not desirable or technically difficult.

Prevail uses paclitaxel, a rapidly absorbed drug, to treat new lesions, small vessel disease, and in-stent restenosis. The company explained that it has improved deliverability and strength compared to previous generation models and can more effectively manage tortuous in vivo environments. It has a thin profile, providing excellent lesion crossing ability.

Oh Seung-sang, Managing Director of Medtronic Korea's Cardiovascular Business Unit, said, "We are pleased to add another option for treating patients with coronary artery disease in Korea through this approval," and added, "We will do our best to ensure that the Prevail drug-coated balloon catheter, which embodies Medtronic's innovative cardiovascular technology, is promptly applied in domestic clinical settings through reimbursement notification."

Prevail has been used in clinical settings since obtaining CE certification in Europe last year, and in Korea, it is scheduled for full launch after reimbursement notification based on this approval and global clinical data.