BrosMed Medical Obtains CE Mark for RevoEdge™ High-Pressure Cutting Balloon
Release time:
2025-01-07
BrosMed Medical is excited to announce that it has obtained CE mark for the RevoEdge High-Pressure Coronary Cutting Balloon under the European Medical Device Regulation (MDR). Redefining the standards of cutting balloons, this cutting-edge device is designed to offer unparalleled cutting performance and crossability.
Unlike traditional glue-fixed blade-type cutting balloons, RevoEdge equips one-piece molded nitinol cutting elements fixed on both ends of the balloon without the use of glue. The superelastic nitinol facilitates higher hardness and lower bending stress getting the ideal balance of exceptional crossability and cutting power, ensuring precise and targeted plaques cutting. This balloon utilizes the elastic compensation design, better conforms to the tortuous vessel, and enhances trackability, further preventing the fish-mouth effects and avoiding vessel trauma. RevoEdge is particularly effective for treating larger-angle angulated lesions (≥45°), a challenge that conventional cutting balloons often fail to address.
RevoEdge also incorporates innovative microcrystalline balloon technology and double-layer balloon material. A thinner yet robust balloon wall greatly improves balloon crossability, optimizes high-pressure resistance, gains an edge in conquering calcified lesions, and minimizes the cause of dissection at the same time. With a high RBP of 20 atm, this state-of-the-art balloon layer design provides minimal balloon deformation and controlled precise dilation. Furthermore, RevoEdge is available in a broader size range, making it suitable for a wider array of clinical applications, especially the treatment of small vessel lesions with the unique 1.5mm balloon diameter, and long diffused lesions with 20mm balloon length.
RevoEdge is a game-changer in complex PCI treatment, combining the latest advances in technologies with a deep commitment to improving patient care. This device will set a new industry benchmark for cutting balloons and provide healthcare professionals with the tools they need to deliver higher safety and better prognosis.
About BrosMed
Specializing in the research, development, manufacturing, and global sales of interventional technologies and products for complex vascular diseases, BrosMed is the industry-leading multinational group in the field of intravascular interventional medical devices. We have over 40 product series and more than 520 product registration certificates worldwide. Our products cover cardiovascular intervention, peripheral intervention, vascular access, neurovascular intervention, and interventional accessories. Our products are marketed in over 100 countries and regions globally.
BrosMed Medical adheres to the mission of "Technologies Embrace Life," actively practices a globalized integration of medical and engineering, and promotes an open innovation model of integrating industry, universities, and scientific research institutions. We are dedicated to continuously providing safe, effective, high-quality, and innovative intravascular interventional solutions for global experts and patients.
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