Brosmed's RevoEdge High-Pressure Coronary Cutting Balloon Receives CE MDR Certification

In the interventional treatment of coronary heart disease, using balloon dilation catheters to achieve vascular expansion is a common therapeutic approach. However, conventional balloon dilation catheters may not achieve ideal treatment outcomes when handling some special and complex lesions alone.

The cutting balloon, as a special balloon that combines micro-cutting technology with a traditional balloon, provides a new option for achieving good therapeutic effects.

With the development of coronary heart disease treatment technology and the promotion of the "intervention without implant" concept, the "cutting balloon," a special type of balloon, has become more familiar to doctors and patients. In clinical applications, especially in some complex lesions, the cutting balloon is playing an increasingly important role, providing new support for coronary heart disease coronary artery intervention treatment and safeguarding heart health.

Unlike traditional glue-fixed blade cutting balloons, RevoEdge is equipped with an integrated nickel-titanium alloy cutting element fixed at both ends of the balloon without the use of glue. Three superelastic nickel-titanium alloy one-piece cutting blades are simpler, sharper, easier for directional vertical plaque cutting, higher in hardness, lower in stress, and avoid irreversible deformation.

Superelastic nitinol helps improve hardness and reduce bending stress, achieving an ideal balance between excellent trackability and cutting ability, ensuring precise and targeted plaque cutting.

The balloon adopts an elastic compensation design, fitting more closely to tortuous vessels, enhancing traceability, further preventing the fish-mouth effect, and avoiding vascular trauma. RevoEdge is particularly effective in treating larger angle angulated lesions (≥45°). The 0.017" ultra-small distal tip outer diameter improves passage through tortuous and narrow lesions, a challenge that traditional cutting balloons typically cannot address.

RevoEdge also adopts microcrystalline balloon technology and double-layer balloon material. The thinner yet stronger balloon wall significantly enhances the balloon's trackability, optimizes high-pressure resistance, and gains an advantage in conquering calcified lesions while minimizing the causes of dissection. With a high RBP of 20atm, this design ensures minimal balloon deformation and controlled precise expansion.

RevoEdge offers a wider range of sizes for broader clinical applications, especially for treating small vessel lesions with a unique 1.5 mm balloon diameter and long diffuse lesions with a 20 mm balloon length.