Editor’s note: An earlier version of this article included inaccurately reported data from the trial. The true results are noted in this article in bullet points. 

The U.S. Food and Drug Administration has granted premarket approval to C.R. Bard’s Lutonix drug-coated balloon to treat stenotic lesions in the arteriovenous fistulae of hemodialysis patients. The Lutonix 035 Drug Coated Balloon PTA Catheter is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel. It was first approved in 2014 to restore blood flow for patients with peripheral arterial disease in the femoropopliteal arteries.

The new indication is for percutaneous transluminal angioplasty (PTA) in stenotic lesions of dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length.

The was based on the results of the Lutonix AV Clinical Trial, the first investigational device exemption trial using drug coated balloons in patients with stenotic lesions in AV fistulae. The follow-up results from randomized patients who were treated with the device demonstrated safety comparable to uncoated balloons.

The catheter also demonstrated a sustained clinical benefit compared to conventional angioplasty through 12 months, including:

  • 71.4% target lesion primary patency at 180 days with superior results at 210 days (DCB 64.1% vs. PTA 52.5%)
  • 31.3% fewer reinterventions compared to conventional angioplasty at six months
  • Nearly two (2) months more reintervention-free days (217 days vs. 163 days) compared to conventional angioplasty
  • 31.2% improvement in target lesion primary patency through 12 months
  • 95% freedom from primary safety event, indicating a consistent safety profile to conventional angioplasty.