C. R. Bard, Inc. (NYSE:BCR) today announced the LUTONIX® 035 Drug Coated Balloon PTA Catheter (DCB) has been granted premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) for a new indication and is now available for sale in the United States. With this approval, the LUTONIX® 035 DCB Catheter becomes the first and only drug coated balloon that is FDA approved as safe and effective in end stage renal disease (ESRD) patients with stenotic lesions in dialysis arteriovenous (AV) fistulae. This latest approval adds to the prior FDA indication of the LUTONIX® 035 DCB Catheter for the treatment of superficial femoral artery (SFA) and popliteal artery disease.

The FDA approval was based on the results of the LUTONIX® AV Clinical Trial, the first investigational device exemption (IDE) trial using drug coated balloons in patients with stenotic lesions in AV fistulae. The follow-up results from randomized patients who were treated with the LUTONIX® 035 DCB Catheter demonstrated safety comparable to uncoated balloons.

The LUTONIX® 035 DCB Catheter also demonstrated a sustained clinical benefit compared to conventional angioplasty through 12 months:
  • 71.4% target lesion primary patency (TLPP) at 180 days with superior results at 210 days (DCB 64.1% vs. PTA 52.5%)
  • 31.3% fewer reinterventions compared to PTA at 6 months
  • Nearly two (2) months more reintervention-free days (217 days vs. 163 days) compared to PTA
  • 31.2% improvement in TLPP through 12 months
  • 95% freedom from primary safety event, indicating a consistent safety profile to PTA

Timothy M. Ring, chairman and chief executive officer, commented, "This approval offers a new treatment option for patients suffering from end-stage renal disease. In line with our continued commitment to deliver products that improve patient care, we are proud to extend the benefits of the LUTONIX® 035 DCB Catheter to help preserve treatment options for U.S. patients."

Globally, there are more than 2 million patients undergoing hemodialysis treatments¹ - each therapy session lasting approximately four hours and occurring up to three times per week - in a hospital or dialysis center.² To receive this therapy, many patients depend on an AV fistula³, which is the connection of an artery to a vein created by a vascular surgeon. For these patients, blockages created by repeated access or narrowing of the blood vessel (restenosis) are a common problem and hinder treatment. Some patients require up to eight reinterventions per year to maintain AV fistula function4, their lifeline for managing renal disease.

"For patients undergoing hemodialysis for kidney failure - who already spend a significant portion of their time undergoing dialysis and other treatments - repeated reinterventions to maintain AV access can be an added burden, with many patients returning as frequently as every other month," said Scott O. Trerotola, M.D., Stanley Baum Professor of Radiology, Associate Chair and Chief, Interventional Radiology, Perelman School of Medicine of the University of Pennsylvania and Principal Investigator of the LUTONIX® AV Clinical Trial. "The LUTONIX® 035 DCB Catheter provides another option for physicians. It's intended to offer patients with end-stage renal disease fewer interruptions in treatment and less time undergoing access maintenance, potentially leading to improved patient satisfaction and quality of life."

About the LUTONIX® AV Clinical Trial

The LUTONIX® AV Clinical Trial included 285 subjects with lesion locations ranging from AV anastomoses at the wrist to the axillosubclavian junction at the shoulder. The trial design incorporated core laboratory evaluations on all patients, monitoring of all data points, independent Clinical Events Committee (CEC) adjudication and Data and Safety Monitoring Board (DSMB) review.

The two-year study is ongoing with additional endpoints at 18 and 24 months.

About the LUTONIX® 035 DCB Catheter

The LUTONIX® 035 Drug Coated Balloon PTA Catheter (DCB) is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel. The new indication is for percutaneous transluminal angioplasty (PTA) in stenotic lesions of dysfunctional native arteriovenous (AV) dialysis ¿stulae that are 4 mm to 12 mm in diameter and up to 80 mm in length.


1 ESRD Patients in 2013: A Global Perspective - Fresenius Medical Care. Available at: http://www.vision-fmc.com/files/ESRD_Patients_in_2013.pdf

2 A to Z Health Guide: Dialysis - National Kidney Foundation. Available at: https://www.kidney.org/atoz/content/dialysisinfo

3 Vascular Access for Hemodialysis- National Institute of Diabetes and Digestive and Kidney Diseases. Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis/vascular-access

4 New Insights into Dialysis Vascular Access: Impact of Preexisting Arterial and Venous Pathology on AVF and AVG Outcomes - Clinical Journal of the American Society of Nephrology. Available at: https://www.researchgate.net/publication/305269023_New_Insights_into_Dialysis_Vascular_Access_Impact_of_Preexisting_Arterial_and_Venous_Pathology_on_AVF_and_AVG_Outcomes

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.

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, 2017 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.

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