Drug Coated Balloon Technology Shows Promising Results

The results of a new clinical study demonstrate the ability of a drug coated balloon to inhibit restenosis in coronary arteries.

Researchers Erasmus Medical Center (Rotterdam, The Netherlands) presented data from the Lutonix De Novo study, an exploratory study investigating the use of the Lutonix Moxy, a paclitaxel-coated balloon used in conjunction with bare metal stents (BMS) in patients with de novo coronary lesions. The pilot study involves 26 patients; it utilized optical coherence tomography (OCT) to provide a high-resolution measure of the biological effect of the Moxy balloon when combined with BMS. The data showed clear inhibition of neointimal hyperplasia along with good stent coverage and safety outcomes at six months, establishing the potential feasibility of the combined therapy for coronary artery disease (CAD). The data were presented at the annual TransCatheter Therapeutics (TCT) conference, held during September 2010 in Washington (DC, USA).


"The biologic effect of the drug coated balloon was absolutely clear. By OCT, neointimal hyperplasia was significantly less than that historically observed for BMS and approaching that of drug eluting stents. There is good strut coverage comparable to second generation drug eluting stents,” said lead author Prof. Patrick Serruys, M.D., Ph.D., of the department of interventional cardiology.

The Moxy drug coated balloon, under development by Lutonix (Maple Grove, MN, USA), delivers paclitaxel to the arterial wall while a carrier molecule facilitates the rapid transfer of the drug to the arterial wall during the single, 30-second inflation. This also allows the Moxy to deliver a therapeutic dose that remains resident in the deep layers of the artery wall, inhibiting restenosis, and at the same time allowing restoration of the inner arterial surface.

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Erasmus Medical Center
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