C. R. Bard, Inc. has announced the enrollment of the first patient into the Lutonix Below the Knee (BTK) Clinical Trial at The 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. If left untreated, patients may face the risk of amputation.
Drug coated balloons have been gaining ground in Europe as solid clinical results suggest the deposition of anti-proliferative drugs on vessel walls during balloon dilatation does prevent vessel restenosis.
The Lutonix® 014 DCB is similar to a standard angioplasty balloon, but is coated with paclitaxel designed to help keep arteries open. Already marketed in Europe 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 new 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. It follows the Levant 2 IDE study in which Lutonix completed enrollment of 476 randomized patients last July for Femoral-Popliteal use.
The global 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).
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.”
Source: C R Bard, Inc., Business Wire
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