FDA Approves Indication for Bard's Lutonix 035 DCB to Treat Dysfunctional AV Fistulas
August 28, 2017—Bard Peripheral Vascular, Inc. announced that the US Food and Drug Administration (FDA) has approved a new indication for the Lutonix 035 drug-coated balloon (DCB), a percutaneous transluminal angioplasty (PTA) catheter. The paclitaxel-coated Lutonix 035 device is now approved by the FDA for use in end-stage renal disease patients with stenotic lesions in dysfunctional native dialysis arteriovenous (AV) fistulas that are 4 to 12 mm in diameter and up to 80 mm in length.
The device, which is available for sale for this new indication, has previously been approved for the treatment of superficial femoral artery and popliteal artery disease.
According to Bard, the FDA approval was based on the results of the LUTONIX AV clinical trial, an investigational device exemption trial using DCBs in patients with stenotic lesions in AV fistulas. The follow-up results from randomized patients who were treated with the Lutonix 035 DCB catheter demonstrated safety comparable to uncoated balloons.
The Lutonix 035 DCB catheter also demonstrated a sustained clinical benefit compared to conventional angioplasty through 12 months, including a 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 PTA at 6 months, approximately 2 months more reintervention-free days (217 vs 163 days) compared to PTA, 31.2% improvement in target lesion primary patency through 12 months, and 95% freedom from primary safety events, indicating a consistent safety profile to PTA.
In Bard's press release, Scott O. Trerotola, MD, the Principal Investigator of the LUTONIX AV clinical trial, commented, "For patients undergoing hemodialysis for kidney failure—who already spend a significant portion of their time undergoing dialysis and other treatments—repeated reinterventions to maintain AV access can be an added burden, with many patients returning as frequently as every other month. The Lutonix 035 DCB catheter provides another option for physicians. It’s intended to offer patients with end-stage renal disease fewer interruptions in treatment and less time undergoing access maintenance, potentially leading to improved patient satisfaction and quality of life.”
Bard stated that the LUTONIX AV clinical trial included 285 patients with lesion locations ranging from AV anastomoses at the wrist to the axillosubclavian junction at the shoulder. The trial design incorporated core laboratory evaluations on all patients, monitoring of all data points, independent Clinical Events Committee adjudication, and Data and Safety Monitoring Board review. The 2-year study is ongoing with additional endpoints at 18 and 24 months.