FDA-Approved Solitaire Flow Restoration Device is a Breakthrough in Clot Retrieval
LANGHORNE, Pa., March 21, 2012 – St. Mary Medical Center became the first Neurosciences Center in the tri-state area to use the Solitaire Flow Restoration Device, after it received U.S. Food and Drug Administration (FDA) approval on March 6, 2012. The device was used to retrieve a blood clot in the brain of an 84-year-old man suffering a major stroke. The Solitaire device is the latest generation in clot-retrieval systems and has demonstrated that it is significantly more effective than previous devices.
In the clinical trial SWIFT (Solitaire With the Intention For Thrombectomy), which was established in January 2010, to determine the effectiveness of the Solitaire Flow Restoration Device, the trial was halted almost a year earlier than planned because of significantly better outcomes reported with the new device.
At the 2012 American Stroke Association’s international conference in New Orleans, UCLA Stroke Center Director Dr. Jeffrey L. Saver reported that research showed that this experimental device for removing blood clots in stroke patients dramatically outperformed the standard mechanical treatment for clot retrieval.
According to the American Heart Association, stroke is the fourth leading cause of death in the U.S. and a leading cause of long-term disability. The majority of strokes are ischemic strokes, which occur when a blood vessel that carries oxygen and nutrients to the brain is blocked by a clot. Stroke is always a medical emergency and the sooner the blood flow can be restored, the better outcome can be expected for the patient.
If a person seeks medical attention with three hours of the onset of stroke symptoms, a clot-busting medication tPA (tissue plasminogen activator) can be effective in many cases to dissolve the clot and restore blood flow. However, as it happens with many cases of stroke, the patient woke up exhibiting signs of stroke and, therefore, the time of the actual onset of stroke was unknown. Previously, the options for safe medical intervention are limited when treatment is delayed.
The Solitaire device is intended to restore blood flow to the brain in patients suffering acute ischemic stroke by mechanically removing blood clots from blocked vessels. The minimally invasive procedure was performed in the specially equipped interventional neurosciences operating room at St. Mary by Dr. Pascal Jabbour, a neurosurgeon with Jefferson Neurosurgical Associates at St. Mary Medical Center. “This is a very promising device that is much more efficient than older devices,” says Dr. Jabbour. “It will change how we treat stroke. The new Solitaire clot-retrieval device provides surgeons with an important tool that expands the timeframe for treating stroke and can significantly reduce the potentially debilitating effects of this serious medical condition.” St Mary was able to perform this procedure utilizing this approved device because of its relationship with Jefferson Neurosurgery.
The Solitaire device in inserted through a small incision in the groin using a thin catheter tube to the location of the clot in the brain. The device has a self-expanding, stent retriever design that compresses and traps the clot. The clot is then removed by withdrawing the device, thus reopening the blocked blood vessel.
The use of the Solitaire device is seen as a means of improving clinical outcomes for stroke patients. Solitaire is more effective in restoring blood flow, less likely to cause bleeding as a side effect of the procedure, reduces mortality, and improves neurologic outcomes in the months following a stroke.