August 8, 2012 — The US Food and Drug Administration (FDA) has approved label changes for the Wingspan Stent System (Stryker) that reflect updated indications, limiting use of the system to a much smaller group of patients with intracranial stenosis.
The Wingspan System was approved in 2005 under a Humanitarian Use Device (HDE) for patients with refractory intracranial atherosclerotic disease with a stenosis of 50% or greater. The changes are based on analysis of the original HDE clinical study and results of the Stenting vs Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study, a statement from FDA notes.
"After reviewing the available safety information, the FDA believes that a very specific group of patients with severe intracranial stenosis and recurrent stroke despite continued medical management – who have not had any new symptoms of stroke within the 7 days prior to planned treatment with Wingspan – may benefit from the use of the device," the FDA statement said. "The agency's assessment of benefits and risks for this device considered that these patients are at serious risk of life-threatening stroke and have limited alternative treatment options."
The SAMMPRIS results, comparing intracranial stenting with aggressive medical management in patients with symptomatic intracranial stenosis, showed that medical management was superior. The advantage was the result of both increased early risk with the stent procedure and better-than-expected results with medical therapy. Results were published last year in New England Journal of Medicine.
In March 2012, the FDA convened an advisory panel to look at the safety and effectiveness of the system. Although panel members agreed that there was no evidence of benefit with use of the system in most patients with stroke or transient ischemic attack (TIA) due to intracranial stenosis, in addition to aggressive medical management like that used in the SAMMPRIS trial, some panel members believed that stenting was still an important option for a small subset of patients.
The FDA analyzed available clinical evidence and concluded that evidence from the original HDE study suggests probable benefit with use of the Wingspan Stent System for a specific population of patients. The FDA determined that Wingspan should remain available for those patients who have failed to respond to, or who are ineligible for, an aggressive and comprehensive program of medical management.
The safety advisory notes specifically that:
"Wingspan is now approved only for patients who are between 22 and 80 years old AND who meet ALL of the following criteria:
who have had 2 or more strokes despite aggressive medical management;
whose most recent stroke occurred more than seven days prior to planned treatment with Wingspan;
who have 70-99% stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes; and
who have made good recovery from previous stroke and have a modified Rankin score of 3 or less prior to Wingspan treatment.
The Wingspan Stent System should not be used for:
the treatment of stroke with an onset of symptoms within 7 days or less of treatment; or
the treatment of transient ischemic attacks (TIAs)."
Specific recommendations for physicians include the following.
For healthcare providers:
"Physicians should be aware that the Wingspan Stent System is approved by the FDA as a Humanitarian Use Device," the statement notes. "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 physician is responsible for obtaining IRB approval before Wingspan is administered to or implanted in a patient."
"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."
"Thoroughly review the revised training program for Wingspan. A summary of these changes [is] 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."
Stryker will be changing physician and patient labeling to reflect these changes, including the new contraindications and warnings and precautions and updated risk and benefit information, the statement adds. "Physicians should expect to receive the new labeling from Stryker and see this labeling in future Wingspan packaging."
Larry B. Goldstein, MD, professor of medicine (neurology) at Duke University Medical Center in Durham, North Carolina, and director of the Duke Stroke Center, was a member of the FDA advisory panel on the Wingspan Stent System. He was among those who advocated for some continued role for the stent, even if it applied to a "vanishingly small" population.
"The FDA approach seems quite reasonable in view of data from the SAMMPRIS trial," Dr. Goldstein told Medscape Medical News. "The device can still be used under the revised HDE in very selected patients who have had recurrent strokes, not TIAs, in the distribution of a significantly narrowed intracranial artery despite adequate medical therapy, who are not severely disabled, and who have significant neurological function at risk."
Under the HDE, he added, the device will have to be used under an IRB-approved protocol, with the requirement of a postmarketing surveillance study to provide additional data on safety and efficacy. "It cannot be used in the treatment of patients with acute stroke," Dr. Goldstein emphasized.
Philip B. Gorelick, MD, MPH, medical director of the Hauenstein Neuroscience Center, Saint Mary's Health Care, and the Department of Translational Science and Molecular Medicine at Michigan State University College of Human Medicine, in Grand Rapids, pointed out that the advent of intracranial angioplasty and stenting provided a welcome strategy for stroke prevention in patients with stenosis in this circulation. Some experts have argued though that advances in medical management of these patients might obviate the need for intervention.
"The SAMMPRIS trial put to the test aggressive medical management versus aggressive medical management plus implantation of the Wingspan stent device to prevent recurrent stroke," Dr. Gorelick said. The trial was halted early because the aggressive medical management group did substantially better than the device implantation treatment group based on early results. "Many were surprised by the findings," he noted.
Based on these results and deliberations of the advisory panel, the FDA has ruled to restrict use of the Wingspan device.
"Some patients who are coached to reduce lifestyle and medical risk factors, as was done in the SAMMPRIS trial, will be successful, but others will not, and strokes will recur," Dr. Gorelick told Medscape Medical News. "Furthermore, the SAMMPRIS trial is an early step in a nascent field of intracranial large artery device implantation, and lessons learned from this trial and its design should be carefully scrutinized as the development of next-generation trial designs moves forward.
"We have not heard the last word about intracranial angioplasty and stenting; however, a cautious position by the US FDA based on robust clinical trial data is merited at this time," he concluded.
The agency says it will continue to monitor and evaluate adverse events associated with the system and results of ongoing follow-up of the SAMMPRIS population and will make available any new information that might affect its use, the statement adds. "In addition, the FDA is requiring Stryker to conduct a postmarket surveillance study (522 Study)," the agency notes, and to share data when they become available.
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Cite this: FDA Limits Use of Stryker Wingspan Intracranial Stent - Medscape - Aug 08, 2012.