BrosMed Medical has obtained CE mark for the RevoEdge high-pressure coronary cutting balloon under the European Medical Device Regulation (MDR). The device is designed to offer unparalleled cutting performance and crossability, BrosMed says in a press release.
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, the press release adds.
The balloon utilises 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, according to the press release.
RevoEdge also incorporates microcrystalline balloon technology and double-layer balloon material. A thinner yet robust balloon wall greatly improves balloon crossability, optimises 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 20atm, this 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.
