China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced that it has received market approval from the Food and Drug Administration of Thailand for its NC Rockstar noncompliant balloon catheter. This development marks a significant step for the company’s expansion into the Southeast Asian medical device market.
Product Composition and Sterilization
The NC Rockstar balloon catheter is a sophisticated medical device consisting of several components, including a TIP head, balloon protective sheath, balloon, balloon inner tube, marker, balloon outer tube, and metal catheter. As a disposable product, it is sterilized using ethylene oxide, ensuring patient safety and reducing the risk of infection. The product boasts a shelf life of three years, providing healthcare facilities with a reliable option for interventional cardiology procedures.
Clinical Applications and Benefits
The NC Rockstar balloon catheter is designed for balloon catheter dilation in cases of stenosis within the autologous coronary artery or bypass graft. This application aims to improve myocardial perfusion in patients suffering from atherosclerosis, offering a treatment option to manage and alleviate symptoms associated with coronary artery disease. Furthermore, the catheter is also suitable for post-delivery expansion of balloon expandable stents, including bare metal and drug-eluting stents, providing versatility in cardiovascular interventions.-Fineline Info & Tech
