SILVER SPRING, Maryland, USA, February 1, 2023 — SINOMED today announced that its SC HONKYTONK™ Semi-Compliant Coronary Balloon Dilatation Catheter has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance further enriches SINOMED’s U.S. coronary product portfolio, complementing the previously cleared NC ROCKSTAR™ non-compliant balloon.
The 510(k) clearance for SC HONKYTONK™ covers balloon dilatation of stenotic segments in coronary arteries or coronary artery bypass grafts. As a semi-compliant balloon, the SC HONKYTONK™ is suitable for both pre-dilatation and post-dilatation during percutaneous coronary intervention (PCI).
Combined with the NC ROCKSTAR™, SINOMED now offers a comprehensive U.S. coronary balloon portfolio covering both pre-dilatation (semi-compliant) and post-dilatation (non-compliant) clinical scenarios, providing U.S. interventional cardiologists with a complete solution for lesion preparation and optimization.
This dual 510(k) clearance achievement represents an important commercial milestone for SINOMED’s U.S. market entry strategy and reinforces the company’s commitment to delivering innovative interventional solutions to physicians and patients worldwide.
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.