Bard Announces First Patient Enrolled in Lutonix Below the Knee (BTK) Clinical Trial
First of its kind global clinical trial to evaluate Lutonix® Drug Coated Balloon (DCB) technology to treat restenosis and occlusions for below the knee peripheral arterial disease
MURRAY HILL, N.J.–(BUSINESS WIRE)–Jun. 4, 2013– C. R. Bard, Inc. (NYSE: BCR) today announced the enrollment of the first patient into the Lutonix Below the Knee (BTK) Clinical Trial atThe Cardiac and Vascular Institute in Gainesville, Florida. The purpose of this pivotal global, multi-center randomized Investigational Device Exemption (IDE) trial is to compare the safety and effectiveness of the Lutonix® 014 Drug Coated PTA Dilatation Catheter to a standard angioplasty balloon for the treatment of critical limb ischemia.
Critical limb ischemia (CLI) is a severe blockage in the arteries of the legs or feet that significantly reduces blood flow. Limbs may develop painful sores, ulcers and/or gangrene (dead tissue) because they do not have enough oxygen. The pain may be severe, can last for hours, and typically occurs at night during rest times. If this condition is left untreated, patients may face the risk of amputation.
The Lutonix BTK clinical trial is expected to enroll several hundred patients at 55 sites worldwide. Patients will be randomized (2:1) for treatment with a Lutonix® 014 DCB Catheter (study arm), or a standard non-coated angioplasty balloon (control arm). The Principal Investigators of the Lutonix BTK clinical trial are:
- Dr. Patrick Geraghty, Associate Professor of Surgery and Radiology atWashington University School of Medicine
- Dr. Jihad Mustapha, Director of Endovascular Interventions, Metro Heart and Vascular, Metro Health Hospital, Wyoming, MI, Associate Professor of Medicine,Michigan State University
- Professor Dr. Marianne Brodmann, Associate Professor and Assistant Medical Director, Division of Angiology, Medical University Graz, Austria
Dr. Arthur Lee from The Cardiac and Vascular Institute stated, “This patient population faces significant challenges and poor clinical outcomes. Drug coated balloons potentially offer a new hope for more durable and long term clinical outcomes for patients facing CLI.”
The Lutonix® 014 DCB is similar to a standard angioplasty balloon, but is coated with an anti-proliferative drug (paclitaxel) designed to help keep arteries open and free from restenosis. The Lutonix® 014 DCB catheter is not commercially available in the United States and is limited to investigational use under an investigational device exemption (IDE). The Lutonix® 014 DCB catheter is commercially available in Europe.
The Lutonix BTK trial is one of several studies designed to produce long term clinical evidence of the Lutonix® drug coated balloon in order to expand treatment options for peripheral arterial disease. Lutonix completed enrollment of 476 randomized patients last July for the Levant 2 IDE study for Femoral-Popliteal use and is actively recruiting patients for the Levant 2 Continued Access Safety Study.
For more information on the Lutonix BTK clinical trial please firstname.lastname@example.org
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 March 31, 2013 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.
Source: C. R. Bard, Inc.
C. R. Bard, Inc.
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