Feature | June 16, 2014

FDA Advisory Panel Unanimously Favors Approval of the Lutonix DCB

Lutonix DCB one step closer to becoming the first FDA-approved drug coated balloon for the treatment of patients with femoropopliteal occlusive disease

FDA Recommendation Lutonix Drug Coated Balloon Catheter

June 16, 2014 — C. R. Bard Inc. announced that the U.S. Food and Drug Administration’s (FDA) Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of the Lutonix Drug Coated Balloon PTA Catheter (DCB) in the United States. The Lutonix DCB is currently under review by FDA for improving luminal diameter and reducing 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. If approved, it is expected that the Lutonix DCB will be the first and only FDA-approved DCB available in the United States.

Data presented at the advisory committee meeting included one-year primary endpoint data from the 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. LEVANT 2 investigators have submitted a manuscript for publication with a top-tier medical journal.

At one year, LEVANT 2 demonstrated superior primary patency of the target lesion with the Lutonix DCB for the efficacy endpoint (73.5% vs. 56.8%, p<0.001 by Kaplan-Meier time-to-event analysis) and non-inferiority for the safety endpoint; both endpoints were compared to standard percutaneous transluminal balloon angioplasty (PTA).

The secondary efficacy endpoint results at one year for patients randomized to treatment with the Lutonix DCB demonstrated superiority in binary restenosis (26.5% vs. 43.2%, p<0.001 by Kaplan-Meier time-to-event analysis at 365 days) 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).

Comparing results to other trials can be challenging and misleading, as each study may have varying patient profiles, protocol structures and other criteria that may affect the reported outcomes. LEVANT 2 raises the bar for scientific rigor in superficial femoral artery (SFA) trials and was designed to reduce bias in the results in order to accurately and scientifically assess and compare the long-term performance of key clinical measures. Two key aspects of the study design differentiate this trial from recent SFA studies. First, unlike some other SFA trials, the LEVANT 2 clinical trial did not count bailout stenting as a primary patency or TLR failure. Second, to reduce the potential introduction of bias into the subjective clinical decision for revascularization, the protocol required the clinical assessment to be performed by a physician who was blinded to the treatment group and the doppler patency measurement.

This methodology of blinding the evaluating physicians in SFA trials is unique to LEVANT 2. Published data suggest that trials with less rigorous blinding methodologies have shown physicians to intervene more often in the control arm than in the treatment arm, even when presented with similar objective results such as binary restenosis. This can have a significant impact on subjective results, such as TLR. For example, the blinding methodology in LEVANT 2 showed very similar rates of intervention when binary restenosis occurred in either arm of the trial. If instead the evaluating physicians in LEVANT 2 had intervened at the rates in unblinded DCB trials when binary restenosis occurred (as estimated from public data), the company estimates the comparable freedom from TLR for LEVANT 2 could have been approximately 94% in the treatment arm compared to approximately 78% in the control arm at one year.

PTA balloons are a well-established and accepted treatment for peripheral arterial disease (PAD) according to the American College of Cardiology and American Heart Assn. guidelines. The Lutonix DCB is a standard angioplasty balloon that is coated with a low dose of the anti-restenotic agent, paclitaxel, and is designed as adjunct therapy to standard mechanical dilatation of the vessel to restore blood flow. Successful treatment of PAD in the femoropopliteal arteries requires improved blood flow (patency) for longer periods of time. PTA is typically the first and preferred method to treat patients with PAD.

“The PAD patient population is growing and the variety of treatment needs for these challenging patients is increasing,” said Kenneth Rosenfield, M.D., section head for vascular medicine and intervention, Massachusetts General Hospital, and LEVANT 2 co-primary investigator. “There is a need to improve upon the current well-established treatment modality and the Lutonix DCB can be another tool to treat PAD in the difficult anatomy of the femoropopliteal artery without leaving an implant behind.”

The FDA will consider the positive recommendation of the advisory panel in its review of the PreMarket Approval (PMA) Application that was submitted by C.R. Bard in November 2013. Currently, the Lutonix DCB is available commercially in Europe.

Timothy M. Ring, chairman and chief executive officer of C. R. Bard, commented, “We are hopeful that the unanimous positive recommendation for Lutonix DCB is the next step in establishing a new standard of care for those patients in the U.S. confronted with femoropopliteal occlusive disease. Clinicians have been calling for a first-line alternative treatment to expand the therapy options for this painful, progressive and debilitating disease and we look forward to working closely with the FDA as it completes its review.”

For more information: www.crbard.com

Related Content

Gore, DrySeal Flex Introducer Sheath, endovascular repair, EVAR
Technology | Vascular Access| August 30, 2016
W. L. Gore & Associates Inc. (Gore) announced the commercial availability of the Gore DrySeal Flex Introducer...
Intact Vascular, TOBA clinical study, one-year results, Tack Endovascular System, Journal of Vascular Surgery
News | Peripheral Arterial Disease (PAD)| August 24, 2016
Intact Vascular Inc. announced that the one-year results from its Tack Optimized Balloon Angioplasty (TOBA) clinical...
Technavio report, renal denervation devices, 2015
News | Renal Denervation| August 23, 2016
August 23, 2016 — Technavio analysts forecast the global...
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
News | Peripheral Arterial Disease (PAD)| August 22, 2016
Avinger Inc. recently announced the closing of its previously announced public offering of 9,857,800 shares of Avinger’...
DMC Heart Hospital, Detroit Medical Center, complex percutaneous intervention education course, PCI, cath lab training
News | Cath Lab| August 22, 2016
The Detroit Medical Center (DMC) Heart Hospital recently completed a Complex Percutaneous Intervention education course...
TAILOR-PCI study, antiplatelet medication, genotype, NHLBI grant
News | Antiplatelet and Anticoagulation Therapies| August 18, 2016
Researchers at the Peter Munk Cardiac Centre, Toronto, and at Mayo Clinic are leading the Tailored Antiplatelet Therapy...
Covidien, Medtronic, TurboHawk, Atherectomy system

The Medtronic TurboHawk atherectomy system. 

Feature | Atherectomy Devices| August 18, 2016 | Dave Fornell
Due to poor outcomes from percutaneous transluminal angioplasty (PTA) ballooning of vessels alone, or of stenting in
Sapien III, Sapien 3, PARTNER III, FDA approval, expanded indication, intermediate risk patients

The Sapien 3 valve has a skirt of fabric at its base that has significantly reduced issues of paravalvular leak, which was an issue with the first generation Sapien device. 

Feature | Heart Valve Technology| August 18, 2016 | Dave Fornell
August 18, 2016 — The U.S.
Corindus Corpath, Acist Medical RXi and CVi, Fairview Southdale Hospital, Minnesota, cath lab
News | Cath Lab| August 17, 2016
Corindus Vascular Robotics Inc. and Acist Medical Systems Inc. are providing Fairview Southdale Hospital, Edina, Minn...
Overlay Init