FDA's Circulatory System Devices Advisory Panel has submitted a unanimous approval recommendation for C.R. Bard's Lutonix Drug Coated Balloon (DCB) Percutaneous Transluminal Angioplasty (PTA) catheter.
If FDA follows the recommendations of the panel, Bard expects that Lutonix will be the first and only FDA-approved non-permanent drug-device combination approved for treating new, or not previously stented, restenotic lesions available in the United States. According to Bard, the device is intended to improve luminal diameter and reduce the incidence of restenosis for the treatment of obstructive de novo or non-stented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries with reference vessel diameters of 4 to 6 mm.
Bard's Executive Summary submitted to FDA says, "Certain vessel areas are not appropriate for stenting, and implantation of a foreign body limits future treatment options. There is a clinical need for a device that is able to achieve more durable patency than PTA without leaving a permanent implant." Enter the Lutonix DCB to fill this gap.
An over-the-wire percutaneous PTA catheter with a paclitaxel-based drug coating on the surface of the balloon, the Lutonix DCB is compatible with a 0.035 in. guidewire. Bard intends to produce the device with balloon sizes ranging from 4 to 6 mm in diameter and 40 to 100 mm in length, in 75, 100, and 130 cm working lengths.
Data presented to the advisory committee included one-year primary endpoint data from Bard's Levant 2 pivotal study, which is a global, prospective, single-blind, randomized, 54-site study (42 sites in the United States and 12 in Europe) that enrolled all patients under one protocol. Bard says the Levant 2 investigators have submitted a manuscript for publication with a top-tier medical journal.
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At one year, according to the company, Levant 2 demonstrated superior primary patency of the target lesion with the Lutonix DCB for the efficacy endpoint and non-inferiority for the safety endpoint; both endpoints were compared to standard percutaneous transluminal balloon angioplasty (PTA).
Bard's data show that the secondary efficacy endpoint results at one year for patients randomized to treatment with the Lutonix DCB demonstrated superiority in binary restenosis when compared to uncoated balloons, and measurable but not statistically significant improvement in freedom from target lesion revascularization (TLR) (89.7% vs. 84.8%, p=0.1673 by Kaplan-Meier time-to-event analysis).
Ingrid Mezo reports that MassDevice.com spoke with some of the panel members. The panel was unanimous, Mezo says, that more patients need to be collected, and for a minimum of 2 years.
"Specifically, we want to know more about longer-term in U.S. women, and we would really like to ideally understand the issue of the relationship to smoking. Some sort of relevant clinical endpoint would be nice, at least covered over the first couple of years," said panel chairman Richard Page, MD, of the University of Wisconsin School of Medicine & Public Health.
Also according to Mezo, Edwin Gravereaux, MD, of Brigham and Women's Hospital in Boston, said, "It certainly proved to be as safe as balloon angioplasty, it possibly met the endpoint for mild improvement, and I look forward to seeing what it can do in the future."
Stephen Levy is a contributor to Qmed and MPMN.
