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Are These Medical Devices Too Dangerous? (Stryker Wingspan Stent System)


Posted in Regulatory and Compliance by Jamie Hartford on April 11, 2014

Stryker Wingspan Stent System 

Approved under an HDE in 2005, the Stryker Wingspan Stent System was greenlighted for use in patients with treatment-resistant (refractory) intracranial atherosclerotic disease who have 50% or greater narrowing in the intracranial arteries.  The device is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. But a 2011 study associated the device with higher than previously thought complication rates and found stenting combined with aggressive medical treatment to be less effective than aggressive medical treatment alone. 

Activists Say:

The message from the trial could not be clearer: The risks of this intervention substantially outweigh any potential benefit to patients. The device poses an imminent threat of serious harm to patients and should be pulled from the market without further delay.”

Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group 

Industry Says:

“Stryker continues to support the Wingspan® Stent System and Gateway® PTA Balloon Catheter as an approved Humanitarian Use Device for improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease who have failed medical therapy. ”

Statement from Stryker

FDA Actions:

2005: Approved Wingspan under a Humanitarian Device Exemption.

2012: Narrowed indications for use. Denied Public Citizen's request to withdraw Wingspan's HDE.

Excimer Lasers Dental Amalgam

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