China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving market approval from the US FDA for its NC Rockstar noncompliant balloon catheter. This marks the first device approval for Sino in the US market, highlighting the company’s expanding global presence.
Product Profile and Features
The NC Rockstar is applicable to balloon catheter dilation for autologous coronary artery or bypass stenosis to improve myocardial perfusion in atherosclerotic patients, as well as post-delivery dilation of balloon dilating stents (bare metal and drug-eluting stents). The product features a double-layer balloon design, balancing the requirements of high bursting pressure and low compliance. The shorter shoulder design and three-layer inner tube design ensure higher balloon expansion accuracy, provide better tracking performance and compression resistance, and effectively prevent guide wire locking during surgery. Compared to other similar products on the market, it has a smaller outer diameter and can achieve full specification kissing with 2.00-4.00mm diameter balloons.
Market Approval and Future Prospects
The NC Rockstar was previously approved for marketing in China in late October. The US FDA approval positions Sino Medical Sciences to further expand its market reach and address significant unmet medical needs in cardiovascular interventions. By leveraging its innovative device technology, Sino aims to improve patient outcomes and contribute to the advancement of global healthcare.-Fineline Info & Tech
