The new indication covers its use as an initial treatment for acute ischemic stroke after the administration of intravenous tissue plasminogen activator and within six hours of symptom onset, Fridley, Minn.-based Medtronic said. The Solitaire device is designed to remove clots from brain arteries using a micro-sized catheter.
“This expanded indication for the Solitaire device demonstrates Medtronic’s ongoing dedication to significantly improving the lives of stroke patients,” neurovascular general manager Stacey Pugh said in prepared remarks. “As the only company with a device studied in all 5 of the global clinical trials responsible for changing the stroke treatment in the American Stroke Assn. guidelines (Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment), we have seen firsthand how stroke patients benefit from this treatment option.”
“Stroke is the 5th leading cause of death in the U.S. and the number one cause of severe disability,” added Dr. Jeffrey Saver of the University of California-Los Angeles. “The availability and access to a technology that reduces stroke disability is critically important because with such innovations, stroke patients and their families may experience less physical, emotional and financial burdens from their condition.”
Medtronic said the expanded clearance was granted based on data from its Swift Prime study of the Solitaire device showing that Solitaire-and-IV-tPA therapy lowered post-stroke disability and raised the number of functionally independent patients after 90 days.