MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. (NYSE: BCR - News) today announced that it has received approval from the United States Food and Drug Administration to market the E•LuminexxTM Vascular Stent. The device is a flexible, self-expanding nitinol stent to be marketed by the Bard Peripheral Vascular Division, located in Tempe, Arizona.
The E•Luminexx™ Vascular Stent is intended to treat patients with common or external iliac artery occlusive disease. Current estimates indicate that each year more than 140,000 patients are candidates for iliac stent procedures in the United States. This patient population is expected to grow by more than 10 percent annually due to the increased clinician focus on treating peripheral arterial disease and the growing number of diabetic patients who are at higher risk of developing these occlusions.
Bard’s prospective, multi-center, non-randomized, clinical study of 134 patients measuring the E•Luminexx™ Vascular Stent against objective performance criteria demonstrated a 9-month primary patency of 94.03% and a site reported anatomic success rate (<30% final residual stenosis) of 98.72%.
Timothy M. Ring, chairman and chief executive officer, commented, “The E•Luminexx™ Vascular Stent joins the recently approved FlairTM Endovascular Stent Graft to position Bard as the only medical device company offering both a stent and a stent graft with peripheral vascular indications in the U.S. The anticipated approval of the LifeStent® FlexStar Stent for the treatment of superficial femoral artery disease will further enhance our comprehensive offerings to address challenges associated with the treatment of peripheral vascular disease.”
C. R. Bard, Inc., (www.crbard.com) is a 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 September 30, 2008 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.
Contact: C. R. Bard, Inc. Investors: Eric J. Shick, 908-277-8413 Vice President, Investor Relations or Media: Holly P. Glass, 703-754-2848 Vice President, Government and Public Relations
Source: C. R. Bard, Inc.
