News | October 24, 2007

Could Drug-Eluting Balloons Substitute DES for CAD?

October 24, 2007 — Drug-eluting balloons could offer a viable alternative to drug-eluting stents (DES) in the treatment of coronary artery disease, according to research results from two studies presented today at TCT 2007, in which one of the studies marked the first direct comparison between DES and drug eluting balloons.

The SeQuent Please drug-eluting balloon catheter (not FDA approved) from B. Braun Melsungen AG in Germany delivers drugs directly to the lesion during angioplasty. A pilot study published last year in the New England Journal of Medicine first shed light on this potential treatment option. (Scheller et, al. “Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter.” New England Journal of Medicine. November 16, 2006. Scheller presented the latest results of his ISR I and ISR II studies at TCT.)

In the PEPCAD II study, Martin Unverdorben, M.D., compared SeQuent Please to another manufacturer’s DES in 131 patients over six months. The team evaluated restenosis and the rate of major adverse cardiac events (MACE) such as heart attack, bypass, repeat stenosis or death. The study showed that patients treated with the drug-eluting balloons experienced only 3.7 percent restenosis and 4.8 percent MACE, as compared to patients with DES, wherein restenosis was 20.8 percent with 22.0 percent MACE rate.

In a separate study, Dr. Unverdorben evaluated the use of drug-eluting balloons for the treatment of small vessel disease in 120 patients. PEPCAD I is the first study to investigate the use of drug-eluting balloons in “native” lesions, in which patients have not already been treated by DES or bare metal stents. After six months, native lesions treated solely with SeQuent Please showed only a 5.5 percent binary restenosis rate and 6.1 percent MACE. These results compare with previously published results using drug-eluting stents for the treatment of small vessel disease with 31.2 percent restenosis and 18.9 percent MACE.

“Although further investigation is needed, drug-eluting balloons alone or in combination with bare metal stents could potentially reduce the use of or replace drug-eluting stents for a wide range of indications,” said Michael Boxberger, M.D., director of Clinical Science, B. Braun Melsungen AG.

For more information:

Related Content

Edwards Lifesciences Recalls IntraClude Intra-aortic Occlusion Device
News | Balloon Catheter | July 15, 2019
Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon rupture during...
Gore Molding & Occlusion Balloon for Endovascular Aortic Repair Receives FDA Approval
Technology | Balloon Catheter | August 23, 2018
W. L. Gore & Associates Inc. (Gore) announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Gore...
Cardiovascular Systems Inc. and OrbusNeich Announce FDA Clearance  of Sapphire II Pro 1mm Coronary Balloon
Technology | Balloon Catheter | March 21, 2018
Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k...
Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions
News | Balloon Catheter | January 24, 2018
Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is...
Abbott recalls its NC Balloon catheters
News | Balloon Catheter | May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Videos | Balloon Catheter | November 16, 2016
A discussion with Todd Brinton, M.D., about the newly FDA-cleared Shockwave Medical Lithoplasty System, at the Transc
NuCryo Vascular, Next Generation Cryoplasty Inflation Device, PolarCath Balloon Dilatation System

PolarCath Balloon Dilatation System image courtesy of NuCryo Vascular

Technology | Balloon Catheter | March 28, 2016
NuCryo Vascular LLC announced the launch of the Next Generation Cryoplasty Inflation device. The device received U.S....
NuCryo Vascular, FDA clearance, next-gen, PolarCath System, cryoplasty inflation device
Technology | Balloon Catheter | January 12, 2016
NuCryo Vascular LLC announced that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance on the...
Videos | Balloon Catheter | October 30, 2015
Todd Brinton, M.D., clinical associate professor and consulting associate professor of bioengineering at Stanford Uni
Overlay Init