SILVER SPRING, Maryland, USA, December 1, 2022 — SINOMED today announced that its NC ROCKSTAR™ Non-Compliant Coronary Balloon Dilatation Catheter has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The NC ROCKSTAR™ becomes the first SINOMED balloon catheter to receive FDA clearance, marking the company’s formal entry into the U.S. coronary balloon segment.
The 510(k) clearance covers the NC ROCKSTAR™ Non-Compliant Coronary Balloon Dilatation Catheter, indicated for balloon dilation of stenotic segments in coronary arteries. As a non-compliant balloon, the device is designed for post-dilatation following stent deployment, providing high-pressure expansion to optimize stent apposition.
This milestone reflects SINOMED’s continued investment in product quality and regulatory affairs, and supports the company’s strategic objective of expanding its interventional cardiology portfolio into the U.S. market. SINOMED intends to launch the NC ROCKSTAR™ in the United States through its established distribution network in the coming quarters.
About SINOMED
SINOMED is a global medical device company engaged in research, development, production, and commercialization of interventional devices. We are focused on developing first-in-class technologies to target unmet clinical needs in the interventional treatment of coronary, neurovascular and structural heart disease. Our mission is to bring the benefits of medical innovation to more patients worldwide, improving both the longevity and quality of their lives.