Demax Gusta Balloons Awarded European CE Certification Under MDR

July 25, 2023—Demax Medical Technology, which is headquartered in Beijing, China, recently announced that the company’s independently developed and manufactured series of Gusta balloons for percutaneous transluminal coronary angioplasty (PTCA) received the CE Mark certificate in accordance with the European Commission’s Medical Device Regulation (MDR).

The company stated that the certification confirms the success of its transitional plan from the previous Medical Device Directive (MDD) to the MDR CE certification. This achievement, which comes after a thorough auditing process, signifies that the Gusta series has met all the necessary requirements and maintains the products’ availability in Europe and other markets that recognize the CE Mark.

Demax noted that he MDR aims to enhance regulatory standards for medical devices and safeguard the safety and health of patients. Compared to the MDD, the MDR imposes stricter certification requirements on medical devices, demanding manufacturers provide more technical and clinical data. As a result, products certified through the MDR offer higher levels of safety and effectiveness.

According to the company, Gusta PTCA balloons can be used to treat a variety of complex lesions such as chronic total occlusions as well as in the jailed balloon technique and the balloon-stent kissing technique.

The Demax Gusta balloon series is designed to provide excellent crossability and trackability. The devices’ features include a tapered head-end design, small lesion entry profile, short tip length, and embedded platinum-iridium alloy marker to reduce outer diameter loss with precise positioning.