The decision by FDA to expand the Trevo's indication could potentially help hundreds of thousands of people experiencing strokes each year.

Chris Newmarker

FDA recently announced that it will allow two Trevo clot retrieval devices to be used as initial therapy for strokes.

The indication is for the Trevo to be used on patients within six hours of symptoms onset of an acute ischemic stroke, or "brain attack." The Trevo should be used after patients receive a clot-dissolving drug (tissue plasminogen activator or t-PA).

"This is the first time FDA has allowed the use of these devices alongside t-PA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of t-PA alone," Carlos Peña, PhD, director of the division of neurological and physical medicine devices at the FDA's Center for Devices and Radiological Health, said in an early September news release.

Hundreds of thousands of people in the United States alone experience ischemic strokes annually. FDA's actions could make the Trevo available to them. When the device was first approved in 2012, it was for stroke patients who could not receive t-PA or for those patients who did not respond to t-PA therapy.

Since then, evidence has mounted that Trevo is a potentially game-changing therapy. A study out of Loyola University this year found the Trevo, as well as the Medtronic Solitaire stent retrievers, did a much better job removing clots from blood vessels in the brain than older technology.

Launched in 2014, Stryker's Trevo XP ProVue Retriever expanded the company's ProVue Retriever line with additional size and shape options for physicians, encouraging ease of use. The device won the Prix Galien USA award in the medtech category that year, and it is competing this year to be declared a "Discovery of the Decade" by the Prix Galien Foundation.

The expanded indication for the Trevo comes on top of other recent good news for Stryker, including the launch of the LITe BIO delivery system. The LITe BIO is a hand-held device meant to facilitate delivery of bone graft material to spinal surgery sites. The LITe BIO's unique design allows surgeons a single-handed method to deliver any type of autograft, allograft, or synthetic bone graft material without visibility obstruction.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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