Maureen Kingsley

November 18, 2016

3 Min Read
Medtronic’s Solitaire Device Earns Expanded FDA Indication to Reduce Stroke-Related Disability

Next goal, says Medtronic, is to ensure hospitals have "protocols in place" to provide this treatment.

Maureen Kingsley

Medtronic announced earlier this week that its Solitaire stent-retriever device has been cleared by FDA for an expanded indication in the treatment of acute ischemic stroke. Medtronic is now free to market the device as an initial therapy for this condition to reduce symptoms of paralysis, speech difficulties, and other disabilities in patients with "a persistent, proximal anterior circulation; large vessel occlusion; and smaller core infarcts," the company explained.

The device uses a micro-sized catheter to access arteries in the brain, helping to restore blood flow and remove large blood clots. It should be used after patients have received intravenous tissue plasminogen activator (IV t-PA), the historically gold standard in ischemic stroke treatment, and within six hours of onset of symptoms.

Gupta

FDA granted Medtronic the expanded indication based on a subset of data from the U.S.-based SWIFT PRIME clinical trial begun in 2012 and completed in early 2015. The study's purpose was to investigate whether patients experiencing an acute ischemic stroke due to large-vessel occlusion who were treated with a combination of IV t-PA and the Solitaire device within 6 hours of symptom onset had less stroke-related disability than those treated with IV t-PA alone.

Manish Gupta, senior director, global medical affairs for Medtronic Neurovascular, explained in an e-mail to Qmed that the resulting data "showed that 62.7% of patients who were treated with Solitaire in addition to IV-tPA were able to regain almost full function at 90 days post-stroke and are able to look after their own affairs without assistance, compared to only 36.8% of patients who were able to do the same when treated with IV t-PA alone."

Gupta also told Qmed, "This expanded indication will further improve patients' access to a technology that reduces stroke disability. Physicians now have clear guidelines from the American Heart Association/American Stroke Association and FDA on when and how to use the Solitaire stent retriever for patients experiencing acute ischemic stroke. The next step will be to ensure that more and more hospitals have treatment protocols in place to provide this technology."

Earlier this year, the SEER study, a meta-analysis of the SWIFT PRIME, REVASCAT, EXTEND-IA, and ESCAPE trials, showed a "strong significance in the numbers needed to treat to reduce disability," Medtronic said. More specifically, for every 2.5 patients treated with the Solitaire device plus IV t-PA, one patient showed improved functional outcomes.

Stacey Pugh, vice president and general manager of Medtronic's Neurovascular business, part of the Restorative Therapies Group, said in a press release that her company has "seen firsthand how stroke patients benefit from this treatment option."

In a previous post on stent-retriever devices and their significance to stroke treatment, Qmed reported on a recent Loyola University (Chicago) study whose authors concluded that stent retrievers are "a major advance in acute ischemic stroke care and will have significant impact on the evolution of stroke systems of care."

Of the 795,000 acute ischemic stroke victims in the United States, about 240,000 are eligible for treatment with stent retrievers. Despite this recommendation, currently only about 22,000 procedures are performed annually.

Maureen Kingsley is a contributor to Qmed.

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