|Covidien gained Canadian approval for its Solitaire FR device.--Courtesy of Covidien|
Covidien ($COV) may have U.S. and regulatory approvals in place for its Solitaire FR, a clot-retrieval device meant to restore blood flow to the brain for patients with acute ischemic strokes. But the company is plowing ahead with a large post-approval study to gather more data on treatment and outcomes.
Up to 800 patients will enroll in the SWIFT PRIME trial in 60 centers around the world, though the trial enrolled its first patient at the University of Buffalo. The randomized controlled trial will examine treating acute ischemic stroke patients treated with intravenous tissue plasminogen activator alone, or in combination with Solitaire FR. Solitaire FR is a stent-based technology that won 510(k) clearance in the U.S. last year, Canadian and Brazilian approvals within the last several months and a CE mark in 2009.
Covidien said the trial will show that the Solitaire FR works better than earlier iterations as far as restoring blood flow to a patient's brain and removing clots before they cause lasting damage, in a procedure known as a mechanical thrombectomy.
Medical device companies typically conduct lengthy studies even after obtaining a device approval. Sometimes, post-marketing trials are a requirement of regulatory approval in the U.S. and elsewhere. But device makers often pursue them anyway because longer-term or wider-use data isn't often available before approval. That new information can help modify a product's use, reinforce its approval status or even support pursuit of a wider indication.
Additionally, Covidien's pursuit of added data will also help it sell the device in the face of some powerful market statistics. The company cites American Heart Association statistics, for example, that note acute ischemic stroke is the major cause of disability in the U.S., and the fourth most common cause of death in the country.
- read the release
Covidien gets Canadian nod for stroke-treating Solitaire
Covidien gets Brazilian approval for stroke device
Neuravi reels in $6.5M Series A for stroke treatment device