C. R. Bard Inc. (BCR) on Monday announced the enrollment of the first patient into the Lutonix Below the Knee clinical trial at The Cardiac and Vascular Institute in Gainesville, Florida.
The purpose of this pivotal global, multi-center randomized Investigational Device Exemption 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 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. 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 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. The Lutonix 014 DCB catheter is commercially available in Europe.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.