Feature | May 03, 2010| Dave Fornell

Companies Developing Drug-Eluting Balloons

The Paccocath coating of the B.Braun SeQuent Please DEB uses contrast media to separate and evenly distribute the paclitaxel molecules over the surface of the balloon. The anti-proliferative drug helps prevent restenosis.

The Paccocath coating of the B.Braun SeQuent Please DEB uses contrast media to separate and evenly distribute the paclitaxel molecules over the surface of the balloon. The anti-proliferative drug helps prevent restenosis.

Several paclitaxel drug-eluting balloons (DEBs) are currently available on the European market, and several others are in development. There are currently no DEBs available in the United States.

In 2009, Invatec launched four DEBs in Europe. The In.Pact Amphirion is designed to treat atherosclerosis in arteries located below the knee. The In.Pact Admiral targets the superficial femoral arteries. The In.Pact Pacific is a 0.018-inch peripheral DEB. The peripheral products offer a size range from 3 to 7 mm diameters, and balloon lengths ranging from 40 to 120 mm. The In.Pact Falcon also was released for coronary vessels.

Medtronic purchased Invatec earlier this year to expand its offerings in peripheral artery disease (PAD) treatments.

B. Braun introduced its SeQuent Please coronary DEB last year in Europe. It uses the Paccocath balloon coating matrix licensed through Bayer AG.

The Dior DEB made by EuroCor was the first DEB to earn a CE mark clearance in 2007. The drug is embedded in its microporous balloon surface, which elutes during a one-minute balloon expansion. A newer generation balloon uses shellac as a carrier.

Aachen Resonance GmbH offers the Elutax DEB in Europe for coronary and small vessels. It also uses a microporous surface.

The Acrostak Genie catheter drug delivery system has two small balloons at the distal and proximal ends of the device. They are inflated under low pressure and the occluded area is flushed with paclitaxel. After an exposure of two minutes, studies revealed the growth of stenosis is permanently inhibited.

Works in Progress

In January 2009, Micell Technologies entered into an agreement with EuroCor to develop a new generation of DEBs. The specific terms of the agreement were not disclosed, but the deal is likely aimed at creating an improved Dior DEB. Micell has developed a unique bioabsorbable polymer coating that is absorbed concurrently with the drug delivery. The technology allows both the polymer and drug to be eliminated within 90 days.

The Genesis DESA (Drug Eluting Scoring Angioplasty), from Genesis Technologies, uses a nitinol mesh braid over the DEB. The braid is supposed to create microfractures in the plaque for better drug delivery.
In the summer of 2009, Lutonix Inc. began patient enrollment for its three simultaneous first-in-human clinical trials to test its Lutonix drug coated balloon catheter. The PERVIDEO I Registry is investigating the DEB’s use in treating coronary bare metal stent in-stent restenosis. The LEVANT I Trial is examining its use in preventing restenosis in the femoropopliteal arteries. The Lutonix De Novo Pilot Study will assess the interaction between bare metal stents and the DEB.

Medrad’s Cotavance DEB uses the Paccocath balloon coating matrix technology from its parent company, Bayer AG. Medrad has submitted a clinical trial request with the U.S. Food and Drug Administration (FDA) and hopes to begin the trial in late 2010.

Cook Medical is currently in European trials with its Advance PTX drug-eluting balloon.
Boston Scientific said it also is developing a paclitaxel-eluting DEB to treat peripheral vessels.
DSM Biomedical develops both medical device coatings and drug delivery coatings, which it is using to create new DEBs.

Related Content

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