Medical devices maker CR Bard Inc. (BCR) 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 Disease (PAD.V).
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 DCB.
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. (MLSS), Steris Corp. (STE) and West Pharmaceutical Services, Inc. (WST). All these stocks carry a Zacks Rank #2 (Buy).
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