Feature | May 03, 2010 | Dave Fornell

Companies Developing Drug-Eluting Balloons


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

News | Balloon Catheter
Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional ...
Home February 25, 2022
Home
News | Balloon Catheter

February 15, 2022 – CERENOVUS, an emerging leader in neurovascular care and part of Johnson & Johnson Medical Devices ...

Home February 15, 2022
Home
News | Balloon Catheter

May 20, 2021 — Boston Scientific Corporation announced it has initiated the AGENT IDE trial for the Agent Drug-Coated ...

Home May 20, 2021
Home
Feature | Balloon Catheter | By Dave Fornell, Editor

The first devices developed for interventional cardiology were percutaneous transluminal coronary angioplasty (PTCA) ...

Home March 16, 2021
Home
Feature | Balloon Catheter

February 17, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Shockwave Medical's Intravascular ...

Home February 17, 2021
Home
News | Balloon Catheter

June 4, 2020 — Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared the XO Score ...

Home June 04, 2020
Home
News | Balloon Catheter

February 24, 2020 — Abbott has voluntarily recalled specific lots of two types of its coronary angioplasty catheters — ...

Home February 24, 2020
Home
News | Balloon Catheter

July 15, 2019 — Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon ...

Home July 15, 2019
Home
Technology | Balloon Catheter

August 23, 2018 — W. L. Gore & Associates Inc. (Gore) announced U.S. Food and Drug Administration (FDA) 510(k) clearance ...

Home August 23, 2018
Home
Technology | Balloon Catheter

March 21, 2018 — Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (FDA) ...

Home March 21, 2018
Home
Subscribe Now