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Covidien Issues STAR Trial Data

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International health care products major, Covidien plc. announced results of the two-year “Solitaire FR Thrombectomy for Acute Revascularization (STAR)” study. Results of the study encourage the use of Covidien’s Solitaire FR device to treat acute ischemic stroke (AIS).

The Solitaire FR device from the company’s Vascular business has been designed to restore blood flow to the brain in patients with AIS. It works by mechanically removing blood clots from blocked vessels. It received CE Mark approval in 2009 and U.S. Food and Drug Administration 510(k) clearance in 2012.

The STAR trial, intended to review the safety and efficiency of the Solitaire FR device, had enrolled 202 patients at 14 centers in Europe, Australia and Canada in May 2010. Data from the study revealed that treatment of intracranial anterior circulation occlusions with the device resulted in lower procedural and device-related risks along with high rates of revascularization. Long-term data, lasting 90 days, indicated lower mortality rate.

Stroke, a potentially fatal condition, is the second leading cause of death globally, according to the medical journal The Lancet. Ischemic stroke occurs when a blood vessel carrying oxygen and nutrients to the brain is clogged. The disease afflicts roughly 800,000 Americans annually, which is expected to go up by 22% in the next 20 years.

We believe that Covidien, a renowned provider of global health care products, is well-positioned to expand in this high-growth stroke care market. The company will use the results of the STAR clinical trial in a Randomized Controlled Trial of the Solitaire FR device against the best medical treatment.
Revenues from the company’s larger Medical Devices segment jumped 8% year over year to $2,133 million in the recently reported first quarter of fiscal 2013. Within Medical Devices, Vascular product sales grew 7% to $414 million, backed by a solid gain across neurovascular and peripheral vascular offerings. The Solitaire FR, which was launched in the U.S. last year, also contributed to the top-line growth.

Covidien currently has a Zacks Rank #2 (Buy). Medical products companies, such as Nxstage Medical, Inc. (NXTM - Free Report) , ResMed Inc. (RMD - Free Report) , Smith & Nephew plc (SNN - Free Report) with Zacks Rank #1 (Strong Buy), are expected to do well.

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