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CR Bard (BCR) Gets FDA’s IDE Approval for Lutonix DCB


CR Bard Inc. BCR recently announced the receipt of an Investigational Device Exemption (IDE) approval from the U.S. FDA for its Lutonix 014 Drug Coated Balloon (DCB) to extend the ‘primary endpoint’ of the product to a 6-month time frame. The Lutonix 014 DCB is an angioplasty balloon which uses a ‘minimal-dosage coating’ of the paclitaxel drug.

Lutonix drug coated-balloon is a flagship platform of CR Bard which is coated with a therapeutic dose of the drug paclitaxel, and is used to treat patients suffering from of peripheral arterial diseases. Under this platform, the approval for the Lutonix 014 device marks the clinical trial for treatment of stenosis or occlusion of arteries below the knee (with a cumulative lesion length up to 320 mm).

Notably, the device has been in commercial use outside the U.S. since 2013. However, in the U.S., the latest development strictly limits the usage of the product for investigational purposes only.

Per management, 340 patients have already enrolled in the clinical trial of Lutonix 014 DCB, of which 69% suffer from diabetes, 95% have critical limb ischemia and 33% are female.



The clinical analysis of Lutonix 014 DCB is free from a ‘major adverse limb event’ and postoperative death up to 30 days. At the end of six months, the analysis promises to present a composition ‘limb salvage’ and ‘primary patency’ to the respective patients.

Meanwhile, CR Bard’s shares witnessed a nominal increase of 0.2% to close at $226.75 following the news release.

Our Take

The latest development is expected to boost CR Bard’s Peripheral PTA line exclusively. This segment has already posted an impressive year-over-year growth of 10% in the last-reported second-quarter of 2016.

Notably, Lutonix 035 DCB is the first drug coated balloon (IDE approved) which is used for the treatment of dysfunctional arteriovenous fistulae under the Lutonix platform. Meanwhile, the company’s Shonin submission for the Lutonix SFA indication is under review in Japan. The company anticipates a mid-2017 launch of this Lutonix product. Undoubtedly CR Bard is gaining prominence with a series of developments under the Lutonix platform, which would significantly enhance the company’s growth trajectory.

An overview of the global market for angioplasty balloons reveals that the market is forecasted to grow at an impressive CAGR of over 3% during 2016 to 2020 (technavio). Buoyed by this trend, we presume CR Bard, with its latest product development, will significantly gain traction over the long haul.

Key Picks

Currently, CR Bard has a Zacks Rank #3 (Hold)

Stocks that warrant a look in the broader medical sector include Halyard Health Inc HYH, Straumann Holding AG SAUHF and Quidel Corp. QDEL. All the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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