The FDA has issued further communication on the subject of Stryker’s Wingspan Neurovascular stent, which it says is only indicated for patients who are at serious risk of life-threatening stroke and have limited alternative treatment options.
Stryker’s Wingspan stent was originally approved by the FDA under Humanitarian Device Exemption rules in 2005 for patients with treatment-resistant (refractory) intracranial atherosclerotic disease with 50 percent or greater narrowing in the intracranial arteries.
Back in August we reported that the FDA had modified its indications for use of the device, based on clinical results from the so-called SAMMPRIS study (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis). Back then it said 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). Furthermore it changed its original approval indication by stating that the device 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).
The agency has now issued an update to that document and in so doing provided more details of the very limited patient group it considers would benefit from use of the device. It’s a pretty exclusive club too, as follows:
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.
Outwith these criteria, FDA reckons data from the SAMMPRIS study suggests Wingspan may present “unacceptable risks, such as stroke and death, to many patients previously considered appropriate for treatment with Wingspan.”
Meanwhile Wingspan’s European study won’t be published until next September, not that any of this has restricted use of the device in Europe. We’ve said it before, and we’ll say it again. When one jurisdiction finds a problem, shouldn’t there be an obligation on others to revisit their approvals?