Icad stroke update#

The FDA also publicly informed health care providers and patients about the revised labeling based on the review of available safety information. In addition, the FDA ordered Stryker to conduct a postmarket surveillance study (Section 522 study), and Stryker initiated the WEAVE study to fulfill the Section 522 study requirement.

Icad stroke update#

In 2012, the FDAВ worked withВ Stryker to update their labeling for the Wingspan device, which included revised indications for use (noted above), based on safety information reviewed and feedback received during a public FDA Neurological Devices Panel of the Medical Devices Advisory Committee meeting held on March 23, 2012. The FDA is providing results from the mandated postmarket surveillance study (Section 522 study) entitled ' Wingspan StEnt System PostmArket SurVEillance (WEAVE)' to inform health care providers and patients that a significantly higher incidence of stroke or death occurred within 72 hours of the procedure when the Wingspan was used in patients outside of the FDA-approved indications for use. Generally, a patient may be treated with Wingspan only if the treating physician has received Institutional Review Board (IRB) approval to use the Wingspan at the clinical site. Humanitarian Use Devices (HUD) eligible for the HDE regulatory pathway are intended to treat or diagnose a disease or condition that affects not more than 8,000 people in the United States per year. Wingspan is approved through the Humanitarian Device Exemption (HDE) regulatory pathway. Lower scores indicate less or no disability. The Rankin scale is used to measure the degree of disability at the time of evaluation. who have made good recovery from the previous stroke and have a modified Rankin Scale score of three or less prior to Wingspan treatment.who have 70-99 percent stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes and.whose most recent stroke occurred more than seven days prior to planned treatment with Wingspan.who have had two or more strokes despite aggressive medical management.Wingspan is FDA-approved only for patients who are between 22 and 80 years old AND meet ALL the following criteria: 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, and there are few treatment options available for managing this condition. This may be referred to as intracranial atherosclerotic disease (ICAD). Intracranial arterial stenosis, or narrowing of arteries, is a serious condition caused by a buildup of plaque within the intracranial arteries. StrykerвЂ™s Wingspan Stent System (Wingspan) is used to open narrowed arteries in the brain of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. Neurointervention, Neurology, Neurosurgery, Neuroradiology Product Institutional Review Boards (IRBs) who approve the use of the Wingspan device.Patients with intracranial arterial stenosis.Health Care Providers: Neurologists, neurosurgeons, and neuroradiologists who perform neurointerventional procedures.