Structural Heart Devices in South Korea: An Overview
Structural heart devices refer to medical devices used to treat defects or abnormalities in the heart's anatomy, particularly the valves, walls, and chambers. In South Korea, the market for structural heart devices has seen rapid growth due to an aging population, increased prevalence of cardiovascular disease, and advancements in minimally invasive procedures.
Key Types of Structural Heart Devices
Transcatheter Aortic Valve Replacement (TAVR/TAVI) Devices
Used to replace a narrowed aortic valve without open-heart surgery.
South Korean hospitals have increasingly adopted TAVR for patients at high or intermediate surgical risk.
Devices used include Edwards Lifesciences' SAPIEN series and Medtronic’s CoreValve, both approved by the Ministry of Food and Drug Safety (MFDS).
Transcatheter Mitral Valve Repair and Replacement
Devices like Abbott’s MitraClip are used for patients with mitral regurgitation.
MitraClip was approved in South Korea and is offered in major cardiac centers such as Asan Medical Center and Severance Hospital.
Newer developments also include investigational transcatheter mitral valve replacement (TMVR) systems being evaluated in clinical trials.
Left Atrial Appendage Closure (LAAC) Devices
Designed to reduce stroke risk in patients with atrial fibrillation by sealing off the left atrial appendage.
Boston Scientific’s WATCHMAN device is available in South Korea and is gaining popularity due to its minimally invasive approach.
Septal Occluders
Used for closing atrial septal defects (ASD), ventricular septal defects (VSD), or patent foramen ovale (PFO).
Devices such as the Amplatzer Septal Occluder (Abbott) are widely used in South Korea’s pediatric and adult congenital heart disease programs.
Market and Regulatory Landscape
South Korea’s Ministry of Food and Drug Safety (MFDS) oversees the approval of structural heart devices, with safety and efficacy requirements similar to those of the FDA and EMA.
The country has a fast-growing medical device industry, with both local companies and global firms actively participating in the structural heart device segment.
Reimbursement policies are evolving to support advanced transcatheter procedures, making treatments more accessible to a wider population.
Local and Global Players in South Korea
Global Companies: Abbott, Medtronic, Edwards Lifesciences, Boston Scientific dominate the South Korean structural heart market.
Local Companies: While most advanced devices are currently imported, South Korean firms such as Genoss and L&K Biomed are entering the cardiovascular device space, with some focusing on stents and catheter-based technologies. Structural heart-specific innovations are beginning to emerge, with support from government R&D initiatives.
Clinical Excellence and Research
Leading hospitals like Seoul National University Hospital, Samsung Medical Center, and Yonsei Severance Hospital are hubs for clinical trials, early adoption, and training in structural heart interventions.
South Korea is also becoming a clinical trial site for new structural heart technologies, thanks to its advanced infrastructure and experienced cardiac centers.
Future Outlook
The structural heart device sector in South Korea is expected to grow steadily, fueled by:
Demographic shifts (aging population)
Rising rates of valvular and congenital heart diseases
Advances in robot-assisted and AI-driven imaging for structural heart planning
Increased investment in domestic medtech innovation
South Korea aims to become not only a consumer of global devices but a producer and innovator in structural heart technology through robust public-private partnerships and academic research.