MURRAY HILL, N.J. — February 9, 2016 — Bard Peripheral Vascular, Inc. (BPV), a subsidiary of C. R. Bard, Inc., a leading developer and manufacturer of medical device technologies used to assist doctors in performing life-saving peripheral vascular surgical procedures, announced today that the Lutonix® 035 Drug Coated Balloon (DCB) PTA Catheter was featured in a series of main stage podium and special session presentations during the Leipzig International Course (LINC) held in Leipzig, Germany, demonstrating continued, confirmatory Lutonix® DCB clinical data.
Sabine Steiner, Senior Physician in the Division of Interventional Angiology in University Hospital Leipzig, Germany, presented the results of an investigator-sponsored and funded retrospective, single-center study comparing real-world patients with complex femoropopliteal lesions treated with Lutonix® and In.Pact™ DCBs. The results revealed no significant difference at 18 months in target lesion revascularization (TLR) and sustained clinical improvement between the Lutonix® DCB and the In.Pact™ DCB. Clinical improvement was measured by improvement in Rutherford class from baseline or prior to DCB treatment.
A total of 575 limbs were treated in symptomatic PAD patients undergoing femoropopliteal intervention (In.Pact™ DCB n= 398; Lutonix® DCB n=177). Patients treated with the Lutonix® 035 DCB demonstrated a freedom from TLR rate of 73.1% at 18 months (n=90), and patients treated with the In.Pact™ DCB demonstrated a freedom from TLR rate of 74.8% at 18 months (n=44).
Improvement in Rutherford class was observed at 18 months in 66.4% of the patients treated with the Lutonix® DCB (n=77) and in 59.5% of the patients treated with the In.Pact™ DCB (n=41)—a 6.9% difference, although, this difference is not statistically significant.
Professor Dierk Scheinert, M.D., Head of the Department of Interventional Angiology at the University of Leipzig in Germany, commented, “These single-center results, like others before, show that real-world patients are benefiting from drug-coated balloon technology; and furthermore, the study indicates that there is no significant difference in the need for revascularization following treatment with either of these two DCBs.”
Globally, nearly 202 million patients suffer from PAD, 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.
About the Lutonix® DCB:
The Lutonix® 035 DCB is an angioplasty balloon coated with a therapeutic dose of the drug Paclitaxel, which utilizes standard mechanical dilatation to restore blood flow for patients with de novo or restenotic lesions of up to 150mm in length in native superficial femoral or popliteal arteries. It was the first drug coated balloon approved by the US Food and Drug Administration in October 2014.
C. R. Bard, Inc. (www.crbard.com), headquartered in Murray Hill, NJ, is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.