Wallstent Endoprosthesis

Approval order statement

APPROVAL FOR THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS RP DELIVERY SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS (12 MM - 16 MM VENOUS ENDOPROSTHESES). THESE DEVICES ARE INDICATED FOR IMPROVING CENTRAL VENOUS LUMINAL DIAMETER FOLLOWING UNSECCESSFUL ANGIOPLASTY IN PATIENTS ON CHRONIC HEMODIALYSIS WITH STENOSIS OF THE VENOUS OUTFLOW TRACT. UNSUCCESSFUL ANGIOPLASTY IS DEFINED AS RESIDUAL STENOSIS >= 30 PERCENT FOR A VEIN <= 10 MM IN DIAMETER OR >= 50 PERCENT FOR A VEIN > 10 MM IN DIAMETER, A TEAR WHICH INTERRUPTS THE INTEGRITY OF THE INTIMA OR LUMEN, ABRUPT LESION SITE OCCLUSION, OR REFRACTORY SPASM. THE VESSELS THAT CAN BE TREATED WITH THE DEVICE ARE THE INNOMINATE AND SUBCLAVIAN VEINS RANGING FROM 8 MM TO 15 MM IN DIAMETER.