Stroke: Covidien battles "failed" clot-removing device study

February 8, 2013 by MassDevice staff

Medical device company Covidien releases 2-year study results combating a government-funded study that questioned the benefit of medical device intervention in stroke patient's future independence.

Covidien's Solitaire FR revascularization device

Medical device maker Covidien (NYSE:COV) touted 2-year study results demonstrating the safety and efficacy of its Solitaire FR revascularization system, combating another recently published study that questioned whether devices like Solitaire in provide long-term benefits to stroke patients.

The Solitaire FR device helps restore blood flow to the brain by removing blood clots that hinder circulation. Stroke patients with blood clots can suffer brain damage or even death if the brain is deprived of proper blood flow for too long.

Covidien's study demonstrated that the Solitaire FR was successful in reopening blocked blood vessels with low rates of adverse events or patient deaths, but a government-funded study questioned whether manual blood clot removal was ultimately better for patients than treatment with drugs alone.

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The current standard of care for stoke patients involves treatment with clot-busting drugs that help dissolve blood clots over time. In a study funded by the National Institutes of Health and the National Institute of Neurological Disorders & Stroke found that patients who underwent manual clot removal, or thrombectomy, didn't see much improvement in overall outcomes when compared with patients who only received a clot-busting drug, IV t-PA, an intravenous tissue plasminogen activator.