|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