RevoEdge™ High Pressure Cutting Balloon

Super elastic nitinol cutting elements

• Single-piece moulded cutting elements provide a strong cutting capability with superior crossability to ensure optimal plaque remodelling
• Super elastic nitinol offers greater strength with reduced bending stress, minimising irreversible deformation and delivering a focused cutting force

Microcrystalline balloon technology with dual-layer balloon material

• A thin but robust material enhances crossability to facilitate lesion access

Non-compliant 20atm RBP

• Consistent and predictable high pressure dilation of calcified or fibrotic lesions

Broad size range to treat a variety of challenging lesions

Ultra-low 0.017" tip entry profile with cutting elements fixed at both ends

• Cutting elements are securely fixed without glue, offering excellent guidewire trackability and avoidance of the fish-mouth effect

Smooth shoulder transition

• For enhanced crossability and safety

Safe and reliable plaque modification

• Trial design: A prospective, multi-centre, randomised, controlled, non-inferiority clinical trial. N=168*
• Test Group: RevoEdge™ , Control Group: W Cutting Balloon

             

Procedural success rate: no balloon-related vascular perforation occurred during balloon dilatation (PTCA), no grade C or higher flow-limiting dissection, and no reduction in TIMI blood flow compared with preoperative levels. Device success rate: complete delivery, inflation and expansion, pressure withdrawal, and withdrawal successfully during balloon dilation of stenotic lesions, and the residual stenos immediately after balloon dilation is 50%. Excellent crossability rate: smoothly crossing through normal lesions without obstruction and demonstrating better conformity to the blood vessels when navigating through complex lesions.

*Data on file

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