![]() ![]() ![]() # COMPLETED.Įxplore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.ĭo you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. of the instructions of use duly approved and published in DOU - Gemat memo 504/2012. # UPDATE: - The company sends a list of customers contacted and the order file for changing the instructions for use, not yet analyzed by the competent technical area. The change was duly petitioned by the registration area. Revised Intended Use / Indications for Use of the Wingspan Stent as follows: Intended Use / Indications for Use The Wingspan® Stent System and Gateway Balloon PTA ™ indicated for use in improving the diameter of the cerebral artery lumen in patients with atherosclerotic lesion intracranial, refractory to medical therapy, in stenosis of intracranial vessels> 50%, accessible by the system. While this is the standard of care for initial treatment of patients with ICAD, the company does not state in the instructions for use of the Wingspan® and Gateway Balloon Catheter® PTA Patient Instructions that patients should be refractory to medical therapy prior to using the Wingspan Stent. Preliminary results from the SAMMPRIS study demonstrated that the use of active medical therapy plus angioplasty and stenting (PTAS) to prevent stroke in patients at high risk for ADHD was no better than active medical therapy per se. In September 2011 preliminary results from the Stenting and Aggressive Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPIRS - Stenting and Active Medical Treatment for Preventing Recurrent Stroke in Intracranial Stenosis) were published in the New England Journal of Medicine New England]. Currently, Boston Scientific continues to manufacture and label these devices on behalf of Stryker. Stryker acquired the Boston Scientific Neurovascular business in early 2011. THIS IS NOT A PROCUREMENT OF THE PRODUCT. ![]()
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