Feature | May 23, 2014

First Drug-Eluting Balloon to Go Before FDA Review Panel in June

May 23, 2014 — The first drug-eluting balloon to go up for review by the U.S. Food and Drug Administration (FDA) will be discussed at the next Circulatory System Devices Panel of the Medical Devices Advisory Committee on June 12 in Germantown, Md.

The committee will discuss, make recommendations and vote on information related to the premarket approval application for the Lutonix 035 drug-coated balloon (DCB). The device was developed by Lutonix Inc., which C.R. Bard acquired in December 2011. The Lutonix drug-coated balloon received European CE mark approval in 2011 and has been the subject of safety and effectiveness testing in the LEVANT 2 U.S. pivotal trial.

The balloon is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter with a paclitaxel-based drug coating on the surface of the balloon. The Lutonix DCB is compatible with a 0.035-inch guidewire and has balloon sizes ranging from 4 to 6 mm in diameter and 40 to 100 mm in length. The catheter is available in 75, 100 and 130 cm working lengths.

The proposed indications for use are for improving luminal diameter for the treatment of obstructive de novo or non-stented restenotic lesions (?15cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 mm to 6 mm.

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.

The six-month data was presented at TCT (Transcatheter Cardiovascular Therapeutics) 2013. 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.”  

For more information: www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm

Related Content

Intensive Glycemic Control Program Produces Significant Per-Patient Cost Savings for CABG Surgery
News | Cardiovascular Surgery| May 25, 2017
A new study from Emory University observed a near-20 percent reduction in perioperative complications, a 1.2-day...
Edwards Lifesciences Centera self expanding transcatheter (TAVR) valve
News | Heart Valve Technology| May 24, 2017
May 24, 2017 — Late-breaking data presented at EuroPCR 2017 demonstrating excellent clinical outcomes for...
3-D Echo Image Analysis With Philips' HeartModel A.I. is Accurate and Reproducible
News | Cardiovascular Ultrasound| May 24, 2017
May 24, 2017 — Philips recently announced the results from a global study indicating that automated...
Heart Failure Mortality Inversely Related to Wealth of Country
News | Heart Failure| May 24, 2017
Death in patients with heart failure is inversely related to the wealth of the country they live in, according to late...
Shockwave Medical Announces CE Mark for Coronary Lithoplasty System and Activities at EuroPCR 2017
News | Cath Lab| May 23, 2017
Shockwave Medical announced last week CE Mark for the company’s Coronary Lithoplasty System for the treatment of...
New Paper Highlights Success of Advanced Treatments in Complex Aortic Aneurysm Repair
News | Endovascular Aortic Repair| May 23, 2017
Significant success has been achieved in treating complex proximal aneurysms using a combination of fenestrated and...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery| May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
News | Heart Failure| May 22, 2017
Serelaxin failed to meet the primary endpoints of the phase 3 RELAX-AHF-2 trial, according to late-breaking results...
Consumers Warned About Accuracy of Heart Rate Apps in New Study
News | Mobile Devices| May 22, 2017
May 22, 2017 — Consumers are being warned about the accuracy of heart rate apps after a study found huge variability
Overlay Init