UPDATED: Biotronik's drug-coated balloon wows with promising 6-month results

Biotronik's Passeo-18 Lux drug-coated balloon--courtesy of Business Wire

Biotronik says an ongoing clinical study has generated promising 6-month results using its Passeo-18 Lux drug-coated balloon to treat leg blood clots, compared to standard balloon angioplasty.

The German device company has been testing the device in the ongoing Biolux P-1 trial, a randomized controlled study at 5 centers in Germany and Austria, looking at how the Passeo-18 Lux drug-eluting balloon treats femoropopliteal arterial disease versus a non-drug-coated version. Biotronik said the drug-coated device, which used paclitaxel, worked better at reducing artery constriction, as well as angiographic late lumen loss, compared to the balloon without the drug.

A drug-coated angioplasty balloon leaves behind anti-clotting medication once a clot is cleared.

Drug-coated balloons aren't very big yet in the U.S., but there is significant interest in the technology. In a sign of the times, device giant C.R. Bard ($BCR) snatched up the venture-backed company Lutonix last December for $225 million to access the its drug-coated percutaneous transluminal angioplasty balloon, which is designed to treat peripheral artery disease. Lutonix's product remains one of the few  FDA-approved IDE trials underway in the U.S. using drug-coated balloons for that indication.  Medtronic began an IDE study in April of its IN.PACT Admiral drug-eluting balloon for the PAD indication.

Bard, which plans to launch the device in Europe by mid-year following a 2011 CE mark, said it sees the global peripheral vascular market for drug-coated balloons reaching $1 billion annually over the next 10 years.

Biotronik is already billing its device as being "very deliverable" and easier to use compared to other technologies. The company presented the results at the EuroPCR 2012 congress on May 17.

Editor's note: Story updated in fourth paragraph to add reference to Medtronic's new IDE study for its IN.PACT Admiral drug-eluting balloon for PAD.

- here's the release

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