Domestic artificial self-expandable pulmonary valve with minimized immune rejection to complete a clinical trial and ready to make headway into the overseas market
Domestic artificial self-expandable pulmonary valve with minimized immune rejection to complete a clinical trial and ready to make headway into the overseas market
- Self-expandable pulmonary valved-stent was developed.
- About to acquire a sales permit from the MFDS and competing to have a dominance in the global market with the US and China
- Expected to reduce importing costs per unit and globally promote Korea's advanced medical technologies
The day when domestic artificial heart value would make headway into the overseas market is right around the corner.
A research team led by Professor Gi-beom Kim of the department of pediatrics & adolescent medicine (Professors Yong-jin Kim and Hong-gook Lim of the department of pediatric thoracic & cardiovascular surgery) at Seoul National University Hospital (SNUH) has successfully completed a clinical trail that implanted the artificial pulmonary valve made from the pericardium of pigs to ten patients through stenting.
Currently there is no available self-expandable artificial pulmonary valved-stent developed by the research team in the market, so that Korea, the United States, and China are in a fierce competition to secure a share of the global market.
If the self-expandable artificial pulmonary valved-stent is put on the market, it will reduce cost worth tens of millions of won involved with importing each prosthetic heart valve and contribute to globalization and national wealth creation with Korea's medical technology.
The research team has begun developing an artificial heart valve with the pericardium of pigs and cows since 2004, at the same time developing a stent used to transplant the prosthetic heart valve through a simple trans-catheter procedure instead of open heart surgery.
The artificial heart valve developed after years of research has almost no immune rejection, which is a differential advantage. This ensures higher durability and safety than other valves developed by the United States and China.
The research team had implanted the prosthetic heart valve into animals since 2011 and obtained a permission from the Ministry of Food and Drug Safety (MFDS) in July 2015 to start the first clinical trial in February 2016. After a decade of research, the team succeeded in implanting the artificial heart valve into the 10th patient in October 2016 and recently completed a follow-up study as well.
Professor Yong-jin Kim said, "Notwithstanding various hardships we've faced for the last ten years and approaches by foreign companies with an offer of joint development, we continued the research to step out into world markets with the domestically-developed artificial heart valve."
The pulmonary valve prevents blood pumped out to the pulmonary artery from flowing back into the right ventricle. If this function does not work properly, blood reflux occurs and the heart fails to pump blood, consequently making it hard for the heart to supply sufficient blood flow throughout the body.
Ten valvular heart disease patients who participated in the clinical trail showed minimized reflux of blood and no immune rejection during the six-month follow-up period. As blood reflux almost disappeared, the volume of the right ventricle reduced by 32.1% on average.
Moreover, as stenting was used instead of open surgery to implant the artificial heart valve, patients were directly moved to not the intensive care unit, but a general ward and stayed in hospital just for four days without any complications.
Today stenting that involves inserting a catheter through the skin into a vein and implanting a stent in the valve area is regarded as a promising option for artificial heart valve replacement.
Currently available self-expandable artificial pulmonary valve and stent is TAVI developed in the United States for elderly patients with aortic valve stenosis. Meanwhile, the artificial self-expandable heart valve developed by the research team is specialized for patients with pulmonary valve disease.
Professor Gi-beom Kim said, "The artificial self-expandable pulmonary valve we've developed is receiving a lot of attention at overseas conferences and symposia." "I hope the heart valve prosthesis by commitment of a lot of medical professionals and the support of the government serves a momentum to upgrade Korea's international status in medicine."