Lutonix, Inc., headquartered in Minneapolis, MN, today announced six-month data from three separate drug coated balloon studies presented at the TransCatheter Therapeutics (TCT) meeting this week demonstrated the ability of the Moxy™ Drug Coated Balloon Catheter to inhibit restenosis in both peripheral and coronary arteries. In all three clinical trials, the drug coated balloon therapy demonstrated a clear biologic effect as measured by six month late lumen loss, a common indicator of arterial restenosis post-procedure. No thromboses were observed in any patient treated with Moxy in any of the three trials. The largest of the studies, LEVANT I, enrolled 101 randomized patients with peripheral vascular disease, and demonstrated a 42% reduction in late lumen loss and trend towards decreased reintervention rates at six months for Moxy by direct comparison to conventional angioplasty control. LEVANT I met its primary endpoint of late lumen loss at six months, 0.46 mm versus 1.09 mm>
Data presented from two coronary studies of the Moxy balloon also demonstrated inhibition of neointimal hyperplasia, the tissue growth that causes restenosis. During a special session of the TCT on drug-eluting stents (DES) and drug coated balloons, Prof. Patrick Serruys (Erasmus Medical Center, Rotterdam) presented data from the Lutonix De Novo pilot study and Dr. Laura Mauri (Brigham and Women's Hospital, Boston) shared the results of the PERVIDEO I study.
The 26-patient Lutonix De Novo study utilized Optical Coherence Tomography (OCT) to provide a high resolution measure of biological effect of the Moxy balloon when combined with bare metal stents (BMS) to treat de novo coronary lesions. The data showed clear inhibition of neointimal hyperplasia along with good stent coverage and safety outcomes at six months, thereby establishing the potential feasibility of this combined therapy for coronary artery disease.
"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 DES. There is good strut coverage comparable to second generation DES," said Prof. Patrick Serruys.
In the single-arm 41-patient PERVIDEO I study examining the safety and feasibility of treating bare metal in-stent restenosis, the Moxy balloon showed a change in percent diameter stenosis of 8.5% during the six month follow-up period and a late lumen loss of 0.16 mm. This late lumen loss data is similar to that achieved in drug-eluting stent and previous drug coated balloon trials for in-stent restenosis. Safety data at thirty days and six months was also similar to comparable trials.
"Although this is a small registry study, it affirms the possibility that drug coated balloons may offer a very useful alternative to stents for treating patients with in-stent restenosis," said Dr. Mauri.
During the Late Breaking Clinical Trials session of TCT, Prof. Dierk Scheinert (Park Hospital and Heart Center Leipzig, Germany) presented the six month outcomes of LEVANT I, a 101-patient prospective, randomized, multicenter study comparing the Moxy balloon to standard balloon angioplasty as treatment for femoropopliteal artery disease in the legs. LEVANT I met its primary endpoint, late lumen loss at six months, with high significance>
"LEVANT I, like the coronary studies, clearly demonstrates the ability to substantially inhibit restenosis through the use of a drug coated balloon," said Prof. Scheinert. "To date, there have been two other randomized trials examining the use of DCBs for peripheral disease. Taken as a whole, these results therefore are not only clinically compelling, but extremely significant in advancing our understanding of this emerging therapy," he added.
LEVANT I sets the stage for LEVANT II, the upcoming IDE trial designed to support the application for US FDA approval. LEVANT II is a global, multicenter trial that will compare the safety and efficacy of the Moxy balloon to standard balloon angioplasty for the treatment of femoropopliteal disease in an even larger patient population.