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. C. R. Bard, Inc. ( www.crbard.com ), headquartered in Murray Hill, N.J., 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. This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current expectations, the accuracy of which is necessarily subject to risks and uncertainties. These statements are not historical in nature and use words such as "anticipate", "estimate", "expect", "project", "intend", "forecast", "plan", "believe", and other words of similar meaning in connection with any discussion of future operating or financial performance. Many factors may cause actual results to differ materially from anticipated results including product developments, sales efforts, income tax matters, the outcomes of contingencies such as legal proceedings, and other economic, business, competitive and regulatory factors. The company undertakes no obligation to update its forward-looking statements. Please refer to the Cautionary Statement Regarding Forward-Looking Information in our June 30, 2015 Form 10-Q for more detailed information about these and other factors that may cause actual results to differ materially from those expressed or implied.
C. R. Bard, Inc. (NYSE:BCR) announced today the presentation of the 12-month results from the Lutonix ® Global Real-World Registry at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 meeting. These results come just months after publication in the New England Journal of Medicine of the 1-year data from the Lutonix ® 035 Drug Coated Balloon (DCB) Catheter pivotal, randomized LEVANT 2 trial. In this registry study, the Lutonix ® 035 DCB demonstrated a freedom from target lesion revascularization (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 93.0% 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." Timothy M. Ring, chairman and chief executive officer, commented, "I would like to thank all of the investigators who participated in the Lutonix ® Global Registry, which continues to generate strong real-world evidence, providing clinicians with an effective alternative to treat their patients who have PAD in femoropopliteal arteries." 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.