China-based Sino Medical Sciences Technology Inc. (SHA: 688108) announced that it has received marketing approval from the Medical Device Authority (MDA) of Malaysia for its NC Rockstar non-compliant coronary artery balloon dilation catheter. The device is designed for balloon catheter dilation of autologous coronary artery or bypass stenosis to improve myocardial perfusion in atherosclerotic patients, as well as for post-delivery dilation of balloon dilation stents, including both bare metal and drug-eluting stents.
Product Advantages and Regulatory Milestones
Compared with other similar products on the market, the NC Rockstar catheter features a smaller outer diameter and can achieve full specification matching with balloons ranging from 2.00 mm to 4.00 mm in diameter. Since its initial approval in mainland China in October 2022, the device has garnered marketing approvals from regulatory bodies in the United States, Thailand, Hong Kong and Taiwan of China, India, Uzbekistan, Pakistan, South Korea, Morocco, Belarus, and Kyrgyzstan.
Global Expansion and Market Potential
The approval from Malaysia’s MDA marks another significant step in the global expansion of Sino Medical Sciences’ NC Rockstar catheter. This regulatory endorsement further validates the device’s efficacy and safety, positioning it as a competitive option in the global market for coronary artery balloon dilation catheters.-Fineline Info & Tech
