FDA Nod for Covidien's Solitaire - Analyst Blog


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International health care products major Covidien ( COV ) has won the green signal of the U.S. Food and Drud Administration ("FDA") for its Solitaire FR revascularization device designed to restore blood flow to the brain in patients with acute ischemic stroke.

The device works by mechanically removing blood clots from blocked vessels. The Ireland-based company said that the product will be available in the U.S. starting April 2012.

Stroke, a potentially fatal condition, is the fourth leading cause of death in the U.S, according to the American Heart Association. Ischemic stroke occurs when a blood vessel carrying oxygen and nutrients to the brain is clogged by a clot. The disease afflicts roughly 700,000 Americans annually.

Solitaire FR's U.S. regulatory application was based on the impressive results from the Solitaire With the Intention for Thrombectomy ("SWIFT") study, in which it was compared with the Concentric Medical Merci Retriever device, a commercially available clot remover. The Solitaire FR demonstrated, in the trial, superior ability in restoring blood flow to the brain within eight hours of stroke onset. 

The Solitaire FR device is already approved outside the U.S. for the endovascular treatment of acute ischemic stroke, offering physicians with an innovative treatment technology over the existing therapy options.

Covidien is a leading global health care products company with a rich history of developing high-quality products in a cost-effective manner. It competes with Johnson & Johnson ( JNJ ), Becton Dickinson ( BDX ) and C.R. Bard ( BCR ), among others.

Revenues from Covidien's core Medical Devices segment climbed 6% year over year to $1.98 billion in the most recent quarter, powered by double-digit growth across Vascular and Energy Devices product-lines.

The Vascular business had another strong quarter with revenues soaring 17% to $387 million, spurred by double-digit growth of venous insufficiency and neurovascular products.

Covidien remains committed to rolling out new products and technologies, focusing on emerging markets, and boosting market share in core segments through investments in sales and marketing infrastructure. However, sustained pricing/procedure volume pressure represents a headwind. We are currently Neutral on the stock, supported by a short-term Zacks #3 Rank (Hold).

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