Earlier this week, Stryker announced FDA 510(k) clearance for the company’s Trevo Pro Retriever (Stryker Corp.), a stent-based device used to retrieve clots from the neurovasculature in acute ischemic stroke (AIS). The clearance makes the Trevo just the fourth mechanical thrombectomy device to receive FDA approval for AIS, along with the Merci Retriever (Concentric Medical Inc./Stryker Corp.), the Penumbra System (Penumbra Inc.), and the Solitaire FR Revascularization Device (Covidien), which received approval in March 2012.
Stryker receives FDA approval for its Trevo Pro Retriever mechanical thrombectomy device
Last week, the FDA announced its decision to narrow the indications for use of the Wingspan intracranial stent sold by Stryker. Approved under a humanitarian device exemption (HDE) in 2005, the device has been plagued by concerns, with recent trial data suggesting that the device can cause more harm than good for some patient populations. The SAMMPRIS trial—comparing use of the Wingspan stent against aggressive medical management for secondary prevention of stroke in patients with atherosclerotic intracranial stenosis—suggested the device was inferior or more dangerous than an aggressive drug regimen. This was followed by an unfavorable FDA advisory panel in March of this year that concluded Wingspan’s benefits did not outweigh its risks in certain patient populations.
FDA restricts indications for use of Stryker's Wingspan intracranial stent in stroke patients
It’s no secret that one of the biggest issues in stroke care is the timely arrival of patients to the hospital. The one FDA-indicated drug available for acute ischemic stroke, IV-tPA, must be used within three hours of stroke onset according to FDA indications. The American Stroke Association, however, updated guidelines in 2009 to extend that window to 4.5 hours. By either treatment window, however, few patients are coming into the hospital to receive tPA.
Little progress seen in arrival times for ischemic stroke