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

News | Cardiac Diagnostics| February 17, 2017
Levels of a protein in the blood associated with heart disease are also linked to early-stage brain damage, according...
Mercator MedSystems, DANCE trial data, ISET, LINC, Bullfrog Micro-Infusion Device
News | Peripheral Arterial Disease (PAD)| February 15, 2017
Mercator MedSystems announced that the national co-principal investigators of the company’s DANCE trial each presented...
Medtronic, IDE approval, IN.PACT Admiral drug-coated balloon, DCB, end-stage renal disease
News | Drug-Eluting Balloons| February 08, 2017
Medtronic plc announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration...
CSI, LIBERTY 360 Study, ISET 2017, six-month data, lower extremity PAD
News | Atherectomy Devices| February 08, 2017
February 8, 2017 — Cardiovascular Systems (CSI) presented six-month data from its LIBERTY 360° post-market study in a
Penn Medicine, heart failure causes, YAP and TAZ proteins, Journal of Clinical Investigation study
News | Heart Failure| February 07, 2017
February 7, 2017 — Of the more than 700,000 Americans who suffer a heart attack each year, about a quarter go on to d
Avinger, VISION Study, two-year outcomes, LINC, Lumivascular technology, Pantheris, OCT-guided atherectomy
News | Atherectomy Devices| February 03, 2017
Avinger Inc. recently announced positive two-year clinical data from the pivotal VISION study of the company’s...
Texas Heart Institute, ischemic heart failure, adult stem cell therapy, CONCERT-HF clinical trial
News | Stem Cell Therapies| February 03, 2017
Physicians and researchers at Texas Heart Institute are recruiting patients who suffer from heart failure to...
Ohio State, Wexner Medical Center, keeping human hearts alive, track abnormal beats, reanimate, Vadim Fedorov

Part of a donated human heart is reanimated and recorded with four high-definition optic cameras in a laboratory at The Ohio State University Wexner Medical Center. Researchers keep the heart tissue alive to look for the causes of irregular heartbeats in cases of persistent atrial fibrillation. Image courtesy of The Ohio State University Wexner Medical Center.

News | EP Lab| February 01, 2017
Researchers have developed a technique that allows them to revive parts of human hearts in the laboratory for up to 12...
CT, computed tomography, IV contrast media, acute kidney injury risk, Annals of Emergency Medicine study

A new study in Annals of Emergency Medicine finds no association between intravenous contrast media used in computed tomography (CT) and kidney damage. Roughly 80 million doses of IV contrast media are given every year. Credit: American College of Emergency Physicians

News | Contrast Media| January 30, 2017
Intravenous contrast media (typically iohexol or iodixanol) used in computed tomography (CT) does not appear to be...
novel blood tests, improved treatment, heart failure patients, Clinical Chemistry, AACC
News | Heart Failure| January 26, 2017
For the first time, researchers have developed tests that could improve treatment for heart failure patients by...
Overlay Init