Feature | November 01, 2013

FDA Pivotal Trial Examines Safety, Efficacy of Drug-Coated Balloon Angioplasty

bard, DEB, drug eluting balloon
bard, DEB, drug eluting balloon
November 1, 2013 — The first clinical trial in the United States to study the use of drug-coated balloons (DCB) for femoropopliteal artery disease found the procedure is promising for safety and efficacy at six months. Six-month data of the LEVANT 2 trial was presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
 
The trial examined the C. R. Bard Inc. Lutonix drug-coated balloon. The primary safety endpoint was composite freedom from all-cause perioperative death and freedom at one year in the index limb from amputation, re-intervention and index-limb-related death. The primary efficacy endpoints were primary patency of the target lesion at one year and absence of restenosis. 
 
LEVANT 2 randomized 476 patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outlflow artery to the foot. After a successful protocol-defined pre-dilation, subjects unlikely to require a stent based on strict angiographic criteria were randomized two-to-one to the treatment with either a drug-coated balloon (DCB) or PTA alone with a standard balloon.
 
At six months by Kaplan-Meier time-to-event analysis, primary patency of the treated vessel was higher among patients treated with a DCB (92.3 percent versus 82.7 percent). Patients treated with DCB experienced similar freedom from major adverse events compared to the PTA group (94 percent in the DCB group and 94.1 percent in the PTA group). Repeat revascularization rates at this interim time point were low and consistent in both groups.
 
“During angioplasty, DCBs are designed to deliver an anti-proliferative drug directly to the tissues of the treated vessel wall, thus inhibiting neointimal hyperplasia and restenosis without the need for a permanent foreign body implant,” said Kenneth Rosenfield, M.D., section head, vascular medicine and intervention, chairman, STEMI and Acute MI Quality Improvement Committee, Massachusetts General Hospital and co-primary investigator of the study. “These findings are an important step toward making this novel treatment available to patients in the United States.”  
 
Bard acquired Lutonix Inc. in December 2011. The Lutonix drug-coated balloon received European CE mark approval in 2011. The device is not commercially available in the United States and is limited to IDE use.
 
The LEVANT 2 trial was funded by C.R. Bard and Lutonix. Rosenfield reported being a consultant for Abbott Vascular; equity in Primacea; research or fellowship support from Abbott Vascular, Atrium, Lutonix-C.R. Bard, and IDEV; board member of VIVA Physicians.
 
For more information: www.crf.org

Related Content

biomimics, 3D stent
News | Peripheral Arterial Disease (PAD)| August 28, 2015
August 28, 2015 — PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania and second in th
iFR, FFR, Philips, Volcano
News | Cath Lab| August 28, 2015
August 28, 2015 — Philips Healthcare is showcasing its latest cardiology solutions at the European Society of Cardiol
News | Heart Failure| August 28, 2015
August 28, 2015 — BioControl Medical said it has completed enrollment in its INOVATE-HF (INcrease Of VAgal TonE in He
Stent graft, computational fluid dynamics, CFD, stent engineering

In this vector velocity model, brighter colors indicate blood flow acceleration as it passes through a bifurcation. Computation fluid dynamic modeling provides insight on blood flow through and near the walls of the stent graft. Image courtesy of Sanford Health

News | Cath Lab| August 27, 2015
August 27, 2015 — The use of computational fluid dynamics (CFD) modeling has been used for years to better engineer l
News | Cath Lab| August 26, 2015
August 26, 2014 — The Cardiovascular Research Foundation (CRF) announced the late-breaking trials and first report in

Mitral regurgitation viewed under color Doppler. Image courtesy of Toshiba.

Feature | Heart Valve Repair| August 26, 2015
August 25, 2015 — Medtronic announced it entered a definitive agreement to acquire Twelve Inc., a start–up medical de
NuCART, CompView Medical, mobile boom system, cath lab, hybrid OR
Technology | Cath Lab| August 21, 2015
August 21, 2015 — CompView Medical announced the release of the NuCART, a turn-key, all-in-one mobile boom system wit
BioSig Technologies, research agreement, UCLA, Pure EP System, EP lab, ventricular tachycardia model, VT
Technology | EP Lab| August 20, 2015
BioSig Technologies announced it has signed a sponsored research agreement with the regents of the University of...
Boston Scientific, Innova vascular self-expanding stent system, FDA approval, peripheral artery disease, PAD
Technology | Stents Peripheral| August 20, 2015
Boston Scientific Corp. has received U.S. Food and Drug Administration (FDA) approval for the Innova Vascular Self-...
Corindus, Corpath, radiation dose monitoring, cath lab, vascular robotic system

The Corindus Corpath vascular robotic system.

Technology | Radiation Dose Management| August 19, 2015
Corindus Vascular Robotics Inc. and Unfors RaySafe Inc., a Fluke Biomedical Company, announced a distribution agreement...
Overlay Init