FDA Safety Communication: Narrowed Indications for Use for the Stryker Wingspan Stent System

Audience:

• Health Care Providers: Neurologists, Neurosurgeons and Neuro Interventionalists
• Patients with intracranial stenosis

Medical and Surgical Specialties: Neuro Intervention, Neurology

Device:
Stryker’s Wingspan Stent System (“Wingspan”) is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. Stenosis, or narrowing of the intracranial arteries, is a serious condition caused by a buildup of plaque within the arteries, and there are few treatment options available for managing this condition. Patients with intracranial stenosis are at serious risk of life-threatening strokes due to reduced blood flow to the brain from narrowed or blocked arteries. The Wingspan stent is intended to reopen narrowed arteries in certain patients to potentially prevent additional strokes.

The FDA approved Wingspan in 2005 as a Humanitarian Use Device (HDE) for patients with treatment-resistant (refractory) intracranial atherosclerotic disease who have 50 percent or greater narrowing in the intracranial arteries. HDE devices are intended to treat or diagnose a disease or condition that affects fewer than 4,000 people in the United States per year.

Purpose:
The FDA is issuing this communication to inform health care providers and patients that the indications for use and labeling for the Wingspan stent have changed to limit the use of Wingspan to a narrow, select group of patients and conditions. These changes are based on analysis of the original HDE clinical study, data from studies performed after the HDE approval was granted, and data from a clinical trial called the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study.

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 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.

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 two 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 percent 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 Rankin scale is used to measure the degree of disability in stroke patients. Lower scores indicate less disability.

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).

Summary of Problem and Scope:
Data collected in clinical studies conducted since HDE approval for Wingspan, including the SAMMPRIS trial, show that Wingspan may present unacceptable risks, such as stroke and death, to many patients previously considered appropriate for treatment with Wingspan.

While Wingspan is not beneficial for the broad population of stroke patients studied in SAMMPRIS, there is evidence from the original HDE study to show there are probable benefits of using Wingspan to treat the specific population of patients outlined in the new indications for use.

The manufacturer will be changing the physician and patient labeling for Wingspan to reflect the new indications for use. The new labeling also includes new contraindications, warnings and precautions and updated risk and benefit information.

Physicians should expect to receive the new labeling from Stryker and see this labeling in future Wingspan packaging.

Recommendations:

Health Care Providers:
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 physician is responsible for obtaining IRB approval before Wingspan is administered to or implanted in a patient.

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.

Patients:
Ask your health care provider if there are other medical management options available prior to considering Wingspan. If your health care provider recommends interventional treatment for intracranial stenosis, talk to him/her about:

• whether you are a good candidate for treatment with Wingspan;
• risks and benefits associated with the use of Wingspan; and
• problems that can occur with the use of Wingspan, and additional medical procedures that may be needed to treat these problems.

FDA Activities:
On March 23, 2012, the FDA convened an expert advisory panel to discuss the most current knowledge regarding the safety and effectiveness of the Wingspan Stent System for the treatment of intracranial stenosis, including the results of the recent SAMMPRIS study. Panel members were asked to discuss the comparability of the patient populations involved in clinical studies of the Wingspan Stent System and how study results may impact the safety and effectiveness of the device. The panel members agreed that there was no evidence of benefit for use of the Wingspan system for most patients with TIA or stroke due to intracranial atherosclerotic stenosis when compared to a program of aggressive comprehensive medical management as was administered in the SAMMPRIS study. Some panelists also suggested that for a certain specific set of patients, Wingspan remains an important option.

The FDA analyzed available clinical evidence and concluded that there is evidence from the original HDE study of probable benefit for the 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 FDA will continue to monitor and evaluate adverse events associated with Wingspan and also monitor the results of ongoing follow-up of patients from the SAMMPRIS study. The agency will make available any new information that might affect its use.

In addition, the FDA is requiring Stryker to conduct a post-market surveillance study (522 study) The FDA intends to share the data, when it becomes available.

Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with the Wingspan Stent System, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.