PTA catheter LUTONIX® 035

blood vesselballoon

Lutonix™ 035 DCB – Dysfunctional AV Fistula Indication First drug coated balloon approved for use in dysfunctional/stenosed dialysis fistulae Features First drug coated balloon approved for use in dysfunctional/stenosed dialysis fistulae Shown to enable longer AV fistula function due to increased time to first reintervention compared to standard angioplasty 71.4% Primary Patency in the Lutonix™ AV Clinical Study at 6 months 31.3% fewer reinterventions than PTA at 6 months in the LUTONIX® AV Clinical Study Demonstrated a safety profile that is as safe as PTA Patients in the Lutonix AV IDE trial experienced 322 reintervention-free days after treatment with Lutonix, compared to 114 with PTA The Lutonix AV Clinical Trial was the first to evaluate the use of a drug coated balloon in dysfunctional AV fistulae. At 24 months, patients who were treated with a Lutonix™ 035 Drug Coated Balloon PTA Catheter went an average of 322 days before needing a reintervention compared to 207 days when treated with PTA alone*. · Broadest Size Offering for AV DCBs† · Lowest Profile AV DCB with All Sizes 7F or Lower · More Intervention-Free Days than Standard PTA Lutonix™ 035 Drug Coated Balloon PTA Catheter Indications for Use: The Lutonix™ Catheter is indicated for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length.