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 U.S. Food and Drug Administration.
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.”
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 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® 035 Drug Coated Balloon PTA Catheter:
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. In the U.S., use of the LUTONIX® 035 DCB in femoropopliteal lesions longer than 150mm is limited by U.S. law to investigational use.
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, 2016 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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Last updated on: 22/09/2016
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