Medical device maker CR Bard Inc. (BCR) recently announced the approval of its Lutonix 035 Drug Coated Balloon (DCB) Catheter by the U.S. Food and Drug Administration (FDA). The device was cleared for percutaneous transluminal angioplasty (PTA), making it the first and only FDA-approved DCB in the U.S.
The latest approval comes on the heels of a unanimous favorable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel in Jun 2014. Notably, the device has been commercially available in Europe since 2012.
CR Bard’s Lutonix 035 DCB combines the advantages of angioplasty balloons (a mechanical technique of widening narrowed or obstructed arteries) and drug-releasing stents, to treat Peripheral Arterial Disease (PAD) in the femoral and popliteal arteries. It provides physicians with an opportunity to enhance the treatment protocol for patients with femoropopliteal occlusive disease.
The FDA approval of Lutonix 035 DCB was supported by results from the LEVANT 2 pivotal study – a global, multi-center, randomized clinical trial, conducted to compare the safety and efficacy of Lutonix 035 DCB against standard angioplasty balloons for the treatment of PAD. The trial demonstrated improved safety and efficacy of the Lutonix 035 DCB when compared to standard PTA.
In the last reported quarter, CR Bard witnessed a double-digit international revenue growth in its peripheral PTA line under the core Vascular segment, driven by favorable sales of the Lutonix 035 DCB. The European response to Lutonix has been particularly remarkable and the company is anticipating sales acceleration in other geographies as well.
For the full year, CR Bard raised its adjusted earnings per share guidance to the band of $8.25–$8.35 from the prior range of $8.20–$8.30. The current Zacks Consensus Estimate of $8.31 lies within the guided range. Constant currency sales growth is anticipated between 8 and 9% for 2014.
Currently, CR Bard has a Zacks Rank #4 (Sell).
Better-ranked stocks in the medical/dental supply industry include The Cooper Companies Inc. (COO), Cardinal Health, Inc. (CAH) and DENTSPLY International Inc. (XRAY). While The Cooper Companies sports a Zacks Rank #1 (Strong Buy), both Cardinal Health and DENTSPLY International carry a Zacks Rank #2 (Buy).
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