First time reported in US, minimally invasive surgery effective for spinal stenosis
08-03-2010
Glendale, CA (PRWEB) August 3, 2010 -- On July 26, 2010 Los Angeles Brain and Spine Institute surgeon, Dr. George Rappard, presented European clinical results for the treatment of lumbar spinal stenosis with the Superion™ Interspinous Spacer (Vertiflex, Inc., San Clemente, CA), at the 7th annual meeting of the Society of Neurointerventional Surgery. These results were presented on behalf of Dr. Walter Bini from Germany, the primary trial surgeon.
Spinal stenosis is a narrowing of the spinal canal that compresses nerves and may cause leg or buttocks pain. The symptoms of lumbar stenosis commonly occur in elderly adults. Over 1.2 million Americans are diagnosed each year with lumbar spinal stenosis and it is the number one reason for surgery in patients over the age of sixty. The Superion™ Interspinous Spacer (ISS) is a medical device designed to relieve chronic pain caused by lumbar spinal stenosis and offers a minimally invasive alternative to traditional spinal surgery. Superion™ ISS is implanted between the spinous processes through a small skin incision. Once in place the device can act as a support column to open the passageways that contain the spinal cord and nerves. This reduces the pressure on the nerves, resulting in pain relief and a return to a more active lifestyle.
As an initial step, this clinical series evaluated the preliminary effectiveness and safety of the Superion™ Interspinous Spacer in patients with mild to moderate lumbar spinal stenosis. The device was implanted in 121 patients affected with lumbar spinal stenosis who had failed conservative measures like therapy, medications and pain injections. At one year patients experienced a 64% improvement in back functions, 49% improvement in back pain and a 53% improvement in leg pain. Quality of life was improved as well, with a 41% improvement in the physical component and a 22% improvement in the mental components of quality of life. Positive trends in patient improvement seen as early as the first month after surgery continued throughout the entire year of follow up. Clinically significant device related complications were seen in 1 (0.8%) of the patients. Dr. Rappard concluded from these data that the Superion™ Interspinous Spacer is potentially an effective and safe treatment option for patients with mild to moderate lumbar spine stenosis.
ISISS trial is the American trial evaluating the Superion™ device for purposes of gaining market approval by the FDA. Having the Superion™ device available in the U.S. would give us an important minimally invasive therapeutic option for treating patients with lumbar spinal stenosis. Dr. Rappard is currently enrolling patients for the American trial. The Superion Interspinous Spacer is currently limited by Federal law to investigational use only and has not been proven safe or effective in the US.
The Los Angeles Brain and Spine Institute provides state of the art comprehensive and minimally invasive brain and spine therapies, including supportive care and cutting edge research. The Institute consists of a seasoned and experienced multi-disciplinary team of neurosurgeons, neurointerventional surgeons, neurocritical care specialists and therapists. Our care is delivered in a compassionate and accessible community based setting.
