Recently, the PTCA guide wire Balancium developed by Lepu Medical has obtained the MDR-CE certificate issued by the BSI Netherlands Notified Body (2797) and is approved for sale in the EU market. Balancium is the first product in Lepu Medical's high-risk category III products to obtain the MDR-CE certificate, and this certificate is also the first MDR certificate for high-risk cardiovascular category III products issued by BSI in China.
With the increasing improvement and development of coronary interventional devices, complicated coronary lesions such as chronic occlusion, severe calcification, distortion, and angulation have gradually become possible, and a high surgical success rate has been made. However, such a disease was relatively difficult to treat in the past. As the most basic platform of coronary intervention, the PCI guide wire plays a pivotal role in the whole process of coronary intervention. The PTCA guide wire Balancium has a soft tip for safe surgery. What's more, its moderate support force meets the delivery needs of commonly used instruments, ensuring effectiveness.
Compared with the Medical Device Directive (MDD), the MDR is stricter in product risk management, product performance safety standards, clinical evaluation, and post-market vigilance and supervision. At the same time, it is also a challenge to the manufacturer's quality management system, product safety, and effectiveness.
Obtaining the first MDR-CE certificate for the Balancium guide wire is only the first step in the CE certificate switching of the coronary intervention product line. The acquisition of the new certificate lays a solid foundation for the company to expand overseas markets. Lepu Medical will accelerate the certificate switching of various products, quickly respond to the regulatory requirements of overseas markets for medical devices, and contribute to the vigorous development of overseas markets.