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LUTONIX® Global Real-World Registry 24-Month Outcomes Presented at VIVA 2016

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09/29/2016 | 07:04pm CEST

By a News Reporter-Staff News Editor at Health & Medicine Week -- value="NYSE:BCR" idsrc="xmltag.org">C. R. Bard, Inc. (NYSE:BCR) announced the presentation of the final 24-month results from the LUTONIX® Global Real-World Registry at the Vascular Intervention Advances (VIVA) 2016 Meeting. These results are the first reported final 24-month outcomes for "real-word" registry data for Drug Coated Balloon PTA Catheters (DCBs). The registry includes a subgroup of patients with long femoropopliteal lesions (>140mm) treated with the LUTONIX® 035 DCB. A Premarket Approval Supplement for use in this subgroup population is currently under review with the value="ACORN:0682203466" idsrc="xmltag.org">U.S. Food and Drug Administration (see also href="http://www.newsrx.com/library/topics/C.-R.-Bard,-Inc..html"> value="NYSE:BCR" idsrc="xmltag.org">C. R. Bard, Inc.).

In this registry study, the LUTONIX® 035 DCB demonstrated a Freedom from Target Lesion Revascularization (TLR) at 24 months by Kaplan-Meier time-to-event analysis of 90.3% for the overall study population of 527 patients and 89.4% for the long lesion (>140mm) subgroup of 106 patients.

Dr. James Benenati, Medical Director of the Peripheral Vascular Laboratory at Miami Cardiac & Vascular Institute commented, "These 24 month outcomes show the therapeutic durability and safety of the LUTONIX® DCB in challenging 'real world' patients with complex femoropopliteal artery lesions."

value="APIN:0408279077">Timothy M. Ring, chairman and chief executive officer, commented, "The LUTONIX® Global Registry continues to generate strong real-world evidence, confirming the sustained effectiveness of the LUTONIX® DCB, which provides clinicians with an alternative to treat patients who have peripheral artery disease (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 value="ACORN:0528653638" idsrc="xmltag.org">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.

Keywords for this news article include: Angiology, value="NYSE:BCR" idsrc="xmltag.org">C. R. Bard Inc.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2016, NewsRx LLC

(c) 2016 NewsRx LLC, source Health Newsletters

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