UCLA Campus    |   UCLA Health    |   School of Medicine Translate:
UCLA Health It Begins With U

Clinical Updates

Print
Email

Clinical Updates

 
Neurology

Blood-clot retriever developed at UCLA outperforms previous-generation device to gain FDA approval

10/16/2012

download the newsletter

Solitaire Flow Restoration Revascularization DeviceA device being tested for removing blood clots from the brains of stroke victims proved so superior to existing technology that the clinical trial was stopped early and the new device was approved in March 2012 by the Food and Drug Administration (FDA) for use in patients. The Solitaire Flow Restoration Revascularization Device, which was developed and tested at UCLA, is a next-generation blood-clot retriever that can restore blood flow in stroke victims and preserve brain cells.

Inserted through a small incision in the groin, the device is threaded through a thin catheter tube to the blood clot in the patient's brain. A self-expanding stent traps and removes the clot, thereby reopening the blocked blood vessel and restoring blood flow to the brain.

Stenting device showed promise as a clot retriever

Originally designed and used for many years as a stent to treat aneurysms, the Solitaire device's potential to remove clots was recently recognized by physicians. Pre-clinical studies in UCLA laboratories confirmed that it could rapidly extract clots from occluded arteries. UCLA led a randomized national clinical trial to compare Solitaire against the Merci Clot Retriever, a corkscrew-like device invented at UCLA nearly a decade earlier.

The study, which included 113 stroke patients at 18 hospitals, found that Solitiare opened blocked vessels without causing symptomatic bleeding in or around the brain in 61 percent of patients. The Merci device removed clots without bleeding in only 24 percent of patients.

The study also found that at 90-day follow-up appointments, 58 percent of patients treated with Solitaire showed good mental and motor functioning compared to 33 percent of patients treated with Merci. Patients randomized to Solitaire also had better survival rates than those treated with Merci.

Clot-retrieval device is a treatment option for ischemic stroke

Stroke is an injury to the brain that occurs due to a blocked or ruptured blood vessel. Also known as a "brain attack," stroke is the fourth-leading cause of death in the United States and a leading cause of adult disability. Ischemic strokes, caused by blood clots or a build-up of plaque in arteries of the brain, are the most common type, accounting for about four out of five strokes. Hemorrhagic strokes, caused by bleeding in the brain, account for the rest.

While some brain cells die within a few minutes of stroke onset, it typically takes about 10 hours for a stroke to kill off an entire region of the brain. The first few hours are critical for preserving brain cells. An FDA-approved drug called tissue plasminogen activator (tPA) is often effective for ischemic stroke patients who receive treatment within the first three hours after a stroke. Patients who have failed to respond to the drug or who are not candidates may be treated with the Solitaire Flow Restoration Revascularization Device up to eight hours following the onset of the stroke.

Clinical trial shows better outcomes with Solitaire

Originally designed as a stenting device to treat brain aneurysm, the Solitaire Flow Restoration Revascularization Device won FDA approval as a clot-remover after a UCLA-led study found it dramatically outperformed another clot retriever invented at UCLA a decade earlier.

The national clinical trial was led by UCLA Stroke Center Director Jeffrey L. Saver, M.D. and included 113 patients at 18 hospitals. Reza Jahan, M.D., a UCLA neurointerventional radiologist who conducted the pre-clinical studies, served as the clinical trial's principal neurointerventional investigator.

The clinical trial compared the Solitaire device with the Merci Clot Retriever, which had been the standard since 2005. The trial showed that patients randomized to have their clots removed with the Solitaire device had less bleeding and better survival rates three months after the procedure than those treated with the Merci device.

"We are pleased that UCLA helped develop and successfully tested a superior, next-generation clot-removing device," Dr. Saver says. Dr. Jahan adds, "It's exciting to have a highly effective new tool that can improve the outcomes for more stroke patients."

Participating Physicians

Jeffrey L. Saver, M.D.
Director, Stroke Neurology

Sidney Starkman, M.D.
Director, Emergency Neurology and Head of Brain Attack Team

Neil Martin, M.D.
Director, Vascular Neurosurgery

Bruce Dobkin, M.D.
Director, Neurological Rehabilitation and Research

Fernando Vinuela, M.D.
Director, Interventional Neuroradiology

Latisha Ali, M.D.
Director, Telestroke Program

David Liebeskind, M.D.
Neurology Director, UCLA Stroke Imaging Program

Gary Duckwiler, M.D.
Interventional Neuroradiology

Reza Jahan, M.D.
Interventional Neuroradiology

Satoshi, Tateshima, M.D. D.M. Sc.
Interventional Neuroradiology

Nestor Gonzalez, M.D.
Neurological Surgery and Interventional Neuroradiology

Contact Information

UCLA Stroke Center
300 UCLA Medical Plaza
Suite B1200
Los Angeles, CA 90095
(310) 794-1195 Appointments

UCLA Stroke Center
Administrative Office
Reed Neurological Research Center
Room 4-126
Los Angeles, CA 90095





Add a comment


Please note that we are unable to respond to medical questions through the comments feature below. For information about health care, or if you need help in choosing a UCLA physician, please contact UCLA Physician Referral Service (PRS) at 1-800-UCLA-MD1 (1-800-825-2631) and ask to speak with a referral nurse. Thank you!


comments powered by Disqus