Stryker's Wingspan stent system has showed a 2.6% observed rate of stroke or death in the Wingspan StEnt System Post MArket SurVEillance Study (WEAVE trial).
The multi-center, prospective and post-market surveillance study has been designed to assess the rate of stroke or death within 72 hours of the procedure in patients treated with the Wingspan stent system.
Wingspan stent system is a self-expanding Nitinol stent and delivery system developed to treat intracranial atherosclerotic disease.
According to the company, the patients suffering from intracranial atherosclerotic disease (ICAD) may benefit from endovascular treatment with the Wingspan stent system.
The trial demonstrated that patients securing on-label treatment with the Wingspan system showed a 2.6% observed rate of stroke or death compared against the pre-specified rate for early success that was established as 4.0% with a minimum 150 patients.
The Gateway PTA balloon catheter is an over-the-wire balloon catheter for pre-dilate the lesion prior to insertion and deployment of the Wingspan stent system.
Wingspan stent system with Gateway percutaneous transluminal angioplasty (PTA) balloon catheter secured approval in the US under a Humanitarian Device Exemption (HDE) and received CE mark approval in 2005.
The federal laws has authorized Wingspan stent system with Gateway PTA balloon catheter to improve cerebral artery lumen diameter in patients 22 to 80 years old with recurrent strokes refractory to a comprehensive regimen of medical therapy and due to atherosclerotic disease of intracranial vessels between 60% and 90% stenosis that are accessible to the system.
Stryker neurovascular division president Mark Paul said: "The WEAVE Trial results are a great step forward for the treatment of intracranial atherosclerotic disease.
“The unprecedented low complication rate shows that endovascular treatment may play an important role in optimizing clinical outcomes for patients suffering from this highly complex disease."
Image: Stryker's Wingspan stent system has demonstrated a 2.6% observed rate of stroke or death in a WEAVE trial. Photo: courtesy of zemicon / FreeDigitalPhotos.net.