Renowned medical devices maker CR Bard (BCR) has enrolled the first patient for its revolutionary Lutonix Below the Knee (:BTK) Clinical Trial. This global, multi-center randomized study is intended to analyze the efficacy of the Lutonix Drug Coated Balloon (:DCB) to treat critical limb ischemia (CLI), thereby expanding treatment options for peripheral arterial disease.
In CLI, blood flow in the arteries below the knees becomes irregular due to an occlusion. This might result in the development of sores, ulcers and even gangrene and if left untreated may lead to amputation of the limb.
In Dec 2011, Bard acquired Minn.-based Lutonix to gain access to its drug-coated percutaneous transluminal angioplasty (“PTA”) balloon. Drug-coated balloons are gaining attention recently as surgeons look for effective means to treat diseased arteries without having to leave a permanent implant. Similar to the drug-eluting stents (“DES”) used in the heart, the drug-coated balloon delivers a powerful restenosis (reoccurrence of stenosis) fighting drug to the artery. However, unlike DES, it is removed from the body after use.
This one-of-a-kind U.S. FDA-approved investigational device exemption (IDE) trial will enroll hundreds of patients across 55 medical centers in the world. Two-thirds of the patients will be treated with the Lutonix 014 DCB Catheter and the rest will be diagnosed with a standard non-coated angioplasty balloon. The only difference between the two is that the former is coated with an anti-proliferative drug (paclitaxel), which helps to keep arteries free from restenosis.
In addition, Bard had completed enrolling patients for its Levant 2 IDE study in Jul 2012, which analyzes drug-coated balloons for treating peripheral arterial disease. The multi-center pivotal study has enrolled 476 patients with significant stenosis (narrowing of a blood vessel) in previously unstented superficial femoral artery or popliteal artery lesions. Moreover, the company is enrolling patients for its Levant 2 Continued Access Safety Study.
The worldwide peripheral vascular market for drug-coated balloons is expected to hit roughly $1 billion annually over the next 10 years. The company has already received European CE Mark for its drug-coated balloon. Currently, there are no approved drug-coated balloons available for use in the U.S.
CR Bard has a Zacks Rank #3 (Hold). Other medical stocks that warrant a look include CONMED (CNMD), Becton, Dickinson and Company (BDX) and West Pharmaceutical Services (WST). All these stocks carry a Zacks Rank #2 (Buy).
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