Stryker Wingspan Stent System Narrowed Indications for Use to Selected Conditions

Healthcare providers and patients are informed by the FDA that Stryker Wingspan Stent System has narrowed indications for use to selected patients and conditions.

Background of Stryker Wingspan Stent System

Wingspan Stent System, by Stryker, is used for the opening of narrowed arteries in the brain in case of intracranial stenosis and in patients who suffer repeated strokes. FDA Alert on Stryker Wingspan Stent System

After the FDA’s revision of the available information from clinical studies and trials the Agency believes that a narrowed group of patients who suffer from severe intracranial stenosis and recurrent stroke may benefit from the use of Stryker Wingspan Stent System. These patients have limited alternative options for treatment and face serious risk of life-threatening stroke.

Recommendation on Stryker Wingspan Stent System

“Physicians should be aware that the Wingspan Stent System is approved by the FDA as a Humanitarian Use Device. Generally, a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB). The Wingspan Stent System should not be used for:

• the treatment of stroke with an onset of symptoms within seven days or less of treatment; or
• for the treatment of transient ischemic attacks (TIAs).

Neurologists:

• Select patients carefully after reviewing the new device labeling.
• Become familiar with the design and results of the SAMMPRIS trial.
• If your patient experiences a complication following treatment with the Wingspan System, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Neuro Interventionalists:

• Thoroughly review the revised training program for Wingspan.  A summary of these changes are included in the new labeling Instructions for Use.
• Report any device problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program.”

Contacting the FDA to report cases with Stryker Wingspan Stent System

In case of detection of adverse events or side effects related to the use Stryker Wingspan Stent System, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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