The presentation of the 12-month results from the Lutonix Global Real-World Registry at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 meeting has been announced by C. R. Bard, just months after publication of the 1-year data from the Lutonix 035 Drug Coated Balloon (DCB) Catheter pivotal, randomised Levant 2 trial in the New England Journal of Medicine.
In this registry study, the Lutonix 035 DCB demonstrated a freedom from target lesion revascularisation (TLR) rate of 94.3% in femoropopliteal arteries at 12 months in 631 patients and, based upon interim data from 170 patients (who were early enrollees), a freedom from TLR rate of 93% at 24 months.
Professor Dierk Scheinert, Head of Department Interventional Angiology at the University of Leipzig in Germany, commented, “The final 12 month results of the Lutonix Global Registry demonstrated how real world PAD patients with complex and long lesions can benefit from this DCB technology without leaving metal behind. Also encouraging are the interim 24 month results which suggest durable benefits of the Lutonix DCB.”
Nearly 202 million patients suffer from PAD globally, which if untreated could lead to serious complications or even death. According to the American Heart Association, PAD affects nearly 8 million Americans with more than 50 percent of cases involving the femoropopliteal arteries in the legs. Patients with femoropopliteal PAD have reduced blood flow to their lower extremities due to narrowed arteries and carry the risk of amputations, a cause of significant physical and psychological burden to patients and substantial costs to the healthcare system.