Renowned medical devices maker
) 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
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.
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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
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
Becton, Dickinson and Company
West Pharmaceutical Services
). All these stocks carry a Zacks Rank #2 (Buy).