Medical devices maker
CR Bard Inc.
) received a unanimous favorable recommendation from the
Circulatory System Devices Advisory Panel of the U.S. Food and Drug
Administration (FDA) for the approval of its Lutonix Drug Coated
Balloon PTA Catheter (DCB) in the U.S.
Lutonix DCB is currently limited to investigational use in the U.S.
under an Investigational Device Exemption (IDE) clinical trial. If
sanctioned, the device is expected to be the first and only
FDA-approved DCB in the U.S.
BCR???s Lutonix DCB combines the advantages of angioplasty balloons
(a technique of mechanical widening of narrowed or obstructed
arteries) and drug-releasing stents, to treat Peripheral Arterial
The device is presently under review by the FDA for improving
luminal diameter and reducing the incidence of restenosis
(narrowing of a blood vessel) for the treatment of PAD in
superficial femoral arteries (SFA).
The advisory committee came up with the undivided recommendation
based on one-year primary endpoint data from the LEVANT 2 pivotal
study. This global, multi-center, randomized clinical trial was
conducted to compare the safety and efficacy of Lutonix DCB against
standard angioplasty balloons for treating PAD.
The FDA will consider the positive recommendation of the advisory
panel in its review of the Pre Market Approval (PMA) application
that was submitted by BCR in Nov 2013. Lutonix DCB is currently
available in Europe along with several other countries.
In the last reported quarter, BCR witnessed double-digit
international revenue growth in its peripheral PTA line under the
core Vascular segment, driven by favorable sales of the Lutonix
Going forward, BCR aims to improve upon the current
well-established methods to treat patients suffering from PAD. It
strives to establish a new standard of care for U.S. patients by
working closely with the FDA as the latter completes its review.
Currently, BCR carries a Zacks Rank #3 (Hold). Better-ranked stocks
in the medical/dental supply industry include
Milestone Scientific Inc.
West Pharmaceutical Services, Inc.
). All these stocks carry a Zacks Rank #2 (Buy).
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