Biotronik launches drug-releasing balloon Passeo-18 Lux in Europe

Biotronik's Passeo-18 Lux drug-releasing balloon--Courtesy of Biotronik

German devicemaker Biotronik launched its Passeo-18 Lux drug-releasing balloon in Europe, backed by stellar results.

The antiproliferative-releasing drug is coated with paclitaxel to treat de novo and restenotic femoropopliteal lesions. Paclitaxel limits the scar tissue around a stent or a balloon, which prevents the vessel from narrowing after the procedure. Biotronik touts easy deliverability of the device using a protective insertion aid and a drug transfer that targets lesion tissue.

Data from a study showed that at 6 months and 12 months, patients treated with the balloon were less likely to need another treatment, according to the company. At 6 months, Passeo-18 significantly kept vessels from narrowing compared to treatment with an uncoated catheter.

"Passeo-18 Lux has demonstrated excellent clinical results and supports our growing confidence in [drug-releasing balloons]," said chief clinical investigator Dierk Scheinert of Park Hospital in Leipzig, Germany, in a statement. "It is very deliverable and easy to use compared with other technologies and treatment options for these demanding vessels."

Despite the EU's reception, companies have had trouble getting a paclitaxel-eluting balloon on the market in the U.S. Medtronic ($MDT) is closing in on a 2015 launch for its own peripheral artery disease-treating device, the IN.PACT Admiral, which has been CE marked since 2008.

Covidien ($COV) isn't far behind, picking up a PAD balloon with excellent 12-month data of its own, and C.R. Bard ($BCR) continues to study its Lutonix balloon with a $225 million investment.

- here's the release

Suggested Articles

Adamis Pharmaceuticals' EpiPen contender Symjepi, which was rejected last year before the EpiPen havoc, won approval from the FDA.

It’s not exactly going to be smooth sailing for Allergan’s multidose bottle version of dry-eye med Restasis. As it finally gets the green light from the FDA, a…

Counting on a novel nasal-spray device to set it apart from its rivals, drug delivery specialist OptiNose is preparing to file its new chronic rhinosinusitis…