BrosMed Medical Obtains CE Mark for RevoEdge™ High-Pressure Cutting Balloon
Release time:
2025-01-07
January 7, 2024 — BrosMed Medical is pleased to announce that it has obtained CE Marking under the European Medical Device Regulation (MDR) for the RevoEdge™ High-Pressure Coronary Cutting Balloon. Designed to support the treatment of complex coronary lesions, RevoEdge™ combines advanced cutting performance with excellent crossability.
January 7, 2024 — BrosMed Medical is pleased to announce that it has obtained CE Marking under the European Medical Device Regulation (MDR) for the RevoEdge™ High-Pressure Coronary Cutting Balloon. Designed to support the treatment of complex coronary lesions, RevoEdge™ combines advanced cutting performance with excellent crossability.
Unlike traditional glue-fixed blade-type cutting balloons, RevoEdge™ features one-piece molded nitinol cutting elements fixed at both ends of the balloon without the use of glue. The superelastic properties of nitinol help achieve an optimal balance between flexibility and cutting performance, enabling precise and targeted plaque modification. Its elastic compensation design allows the balloon to better conform to tortuous vessels and enhance trackability, while helping reduce fish-mouth effects and minimize the risk of vessel trauma. RevoEdge™ is designed to support the treatment of angulated lesions, including lesions with larger angulation angles of ≥45°, which may present challenges for conventional cutting balloons.
RevoEdge™ also incorporates innovative microcrystalline balloon technology and a double-layer balloon material design. The thinner yet robust balloon wall is intended to improve crossability, enhance high-pressure resistance, support the treatment of calcified lesions, and help reduce the risk of dissection. With a rated burst pressure of 20 atm, the advanced balloon layer design supports controlled and precise dilatation with minimal balloon deformation.
In addition, RevoEdge™ is available in a broad size range to meet diverse clinical needs. The portfolio includes a 1.5 mm balloon diameter option for small vessel lesions and a 20 mm balloon length option for long diffuse lesions.
RevoEdge™ represents BrosMed’s continued commitment to advancing complex PCI treatment through technology innovation. By combining cutting performance, crossability, and controlled dilatation, RevoEdge™ provides physicians with a dedicated tool for the treatment of challenging coronary lesions and reflects BrosMed’s ongoing mission to support improved patient care.
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