Feature | Drug-Eluting Balloons | July 08, 2015

C.R. Bard Announces Results of Levant 2 Study of Lutonix Drug Coated Balloon

Device shows superior primary patency over standard percutaneous transluminal angioplasty for peripheral arterial disease

C.R. Bard, LEVANT 2 results, Lutonix 035 DCB, drug coated balloon, PTA

July 8, 2015 - C.R. Bard Inc. announced the publication of results from the LEVANT 2 study in the June 24, 2015, online issue of The New England Journal of Medicine. Results from LEVANT 2 demonstrated superior primary patency for the Lutonix 035 drug coated balloon percutaneous transluminal angioplasty (PTA) catheter over standard PTA, as well as safety consistent with standard PTA balloons. The Lutonix 035 DCB is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoropopliteal arteries.

The device was the first drug coated balloon approved by the U.S. Food and Drug Administration (FDA) in October 2014. This approval followed a unanimous favorable recommendation from the FDA's Circulatory Systems Devices Advisory Panel.

The LEVANT 2 pivotal study 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, comparing the Lutonix 035 DCB with standard PTA.

According to Kenneth Rosenfield, M.D., M.H.C.D.S., section head, vascular medicine and intervention, in the Division of Cardiology and Fireman Vascular Center at Massachusetts General Hospital, who was principal investigator for the study, "LEVANT 2 followed a rigorous blinding protocol, which was designed to reduce bias in the results. In addition to superiority in primary patency, the paclitaxel-coated balloon used in the study also demonstrated sustained improvements in Rutherford category from baseline to 12 months, and improved patient-reported walking distance scores."

For more information: www.crbard.com

Related Content

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
Lesion Preparation Via Atherectomy Enhances Paclitaxel Distribution in Calcified Peripheral Arteries
News | Peripheral Artery Disease (PAD)| September 20, 2017
September 20, 2017 — Not-for-profit preclinical research institute CBSET announced that its scientists have published
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Overlay Init