C.R. Bard ($BCR) is working hard to show the versatility of its Lutonix drug-coated balloon, even before it wins FDA approval. A few years after acquiring the technology in a $225 million grab of a company with the same name, the first human patient has joined a new trial testing the device below the knee.
Several hundred patients are expected to enroll in what is dubbed the "Lutonix Below the Knee (BTK)" trial, which will be conducted at 55 sites around the world; the first patient had the procedure at a site in Florida. Here's the gist: The trial will compare the Lutonix 014 drug-coated PTA dilatation catheter to a standard angioplasty balloon in patients with critical limb ischemia, where arteries in the legs or feet are severely blocked (leading to amputation risks). Patients will be randomized 2 to 1 for treatment with the Lutonix catheter or a standard noncoated angioplasty balloon, with a hope of generating stellar safety and effectiveness results.
A randomized 476-patient trial completed enrollment last July as part of the Levant 2 IDE study to test the treatment for femoral-popliteal use. Meanwhile, recruitment continues for the Levant 2 Continued Access Safety Study. The product has three human trials behind it so far, with tests in both coronary and peripheral arteries, and more than 40 preclinical studies, according to the company's website. It has had a CE mark in Europe since 2011.
While Bard is pursuing multiple uses for the Lutonix drug-coated balloon, at least one rival is further along, at least in the U.S. Medtronic ($MDT) said it will submit the first part of its PMA submission over the summer for its IN.PACT Admiral drug-eluting balloon, with a hope of launching the novel angioplasty device by late 2014. Biotronik, meanwhile, is plowing ahead with its Passeo-18 Lux drug-coated balloon to treat leg blood clots.
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