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FDA Limits Use of Wingspan Brain Stent | cialis online

FDA Limits Use of Wingspan Brain Stent

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The U.S. Food & Drug Administration (FDA) is limiting use of Stryker Wingspan brain stent and is informing health care providers and patients that device indications for use and labeling have changed. The device is now limited to a narrow, select group of patients and conditions.

Changes to the Wingspan stent were based on an analysis of the original Humanitarian Device Exemptions (HDE) clinical study, data from studies performed after HDE approval was granted, and data from the “Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis” (SAMMPRIS) clinical trial. The Wingspan was approved as an HDE for patients diagnosed with treatment-resistant (refractory) intracranial atherosclerotic disease with 50 percent or more narrowing of the intracranial arteries. HDE devices are meant for the treatment or diagnosis of a disease or condition affecting less than 4,000 people in the United States annually.

The device could cause more harm versus traditional anti-clotting drugs, said NewsInferno. Originally developed by Boston Scientific, the device was acquired by Stryker last year. At the same time, concerns about Wingspan’s safety increased following release of a study published in the New England Journal of Medicine revealing that Wingspan patients experienced a 2.5-fold increase of stroke or death versus patients taking blood thinners. The findings prompted the study to be halted early.

NewsInferno also noted that the FDA allowed Boston Scientific to apply for the Wingspan‘s approval under its HDE program, which allows clearance of a device without proof of device safety or efficacy. HDE approvals are permitted if a device addresses rare diseases or conditions and the manufacturer can show development costs could exceed its financial returns for diseases affecting small patient populations. The Wingspan Stent is the only system currently approved by the FDA for specific high-risk stroke patient. Of note, its 2005 approval was based on one, uncontrolled study involving just 45 patients; the study was not designed to prove Wingspan Stent efficacy or safety over medical therapy alone.

The agency said it believes that patients diagnosed with severe intracranial stenosis and recurrent stroke—despite continued medical management—and who have not experienced new symptoms of stroke within the seven days prior to the planned Wingspan treatment can benefit from the Wingspan stent. The agency’s risk/benefit assessment, according to the FDA Safety Communication, for the Wingspan considered that this specific patient demographic is at significant risk for suffering potentially fatal stroke and has limited alternative treatment options. The Safety Communication can be accessed at

The Wingspan is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis suffering from repeat strokes. Stenosis, the narrowing of intracranial arteries, is a serious condition resulting from arterial plaque build-up; few treatment options are available to patients managing this condition. Patients diagnosed with intracranial stenosis are at serious risk of life-threatening strokes because of reduced blood flow to the brain from their narrowed or blocked arteries.

Wingspan is now approved only for patients 22-80 years of age who have had two or more strokes, despite aggressive medical management; whose most recent stroke occurred more than seven days prior to planned Wingspan treatment; have 70-99 percent stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes; and have made good recovery from previous stroke and have a modified Rankin score of three or less prior to Wingspan treatment. The Rankin scale is used to measure the degree of disability in stroke patients. Lower scores indicate less disability.

The manufacturer will change physician and patient labeling for Wingspan to reflect the new indications for use; the new labeling includes new contraindications, warnings and precautions, and updated risk and benefit information. The FDA has also required Stryker to conduct a post-market surveillance study.

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