International health care product major, Covidien plc. , has initiated a new study, SWIFT PRIME. The main objective of this study is to find out the efficacy of the Solitaire FR Revascularization Device to treat acute ischemic stroke.
Stroke 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.
The Solitaire FR device, an overlapping stent-based technology, mechanically removes blood clots from blocked vessels, restoring blood flow to the brain in patients ailing from stroke. The device has won the approval of the U.S. Food and Drug Administration (“FDA”) in March 2012 and 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.
The new clinical trial has enrolled its first patient at the Buffalo University and may enroll roughly 800 patients across 60 medical centers worldwide. Deemed to be one of the largest global medical studies, it will examine the effectiveness of mechanical thrombectomy using the Solitaire device in stroke care. The trial will also incorporate a health economic analysis.
The Solitaire FR offering from Covidien’s Vascular business under the core Medical Devices segment is gaining significant market share, as evidenced by the 4% year-over-year growth experienced by the Vascular business in the last reported quarter. However, the company's product offerings under its larger Medical Device segment are similar to some of its competitors like Johnson & Johnson (JNJ - Free Report) , Becton, Dickinson and Company (BDX - Free Report) and CR Bard Inc. (BCR - Free Report) .
Covidien currently carries a Zacks Rank #3 (Hold), which supports our long-term Neutral recommendation on the stock.